As filed with the Securities and Exchange Commission on April 12, 2005.                                        Registration No. 333-_______

UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________

FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933

STAAR SURGICAL COMPANY
(Exact name of registrant as specified in its charter)
_________________

            Delaware

                        95-3797439

  (State or other jurisdiction (I.R.S. Employer Identification No.)
of incorporation or organization)

1911 Walker Avenue
Monrovia, California 91016
(626) 303-7902

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
_________________

John Bily
Chief Financial Officer
STAAR Surgical Company
1911 Walker Avenue
Monrovia, California 91016
(626) 303-7902

(Name, address, including zip code, and telephone number, including area code, of Agent for Service)

Copies to:

Su Lian Lu, Esq.
Sheppard, Mullin, Richter & Hampton LLP
333 South Hope Street, 48th Floor
Los Angeles, California 90071
(213) 620-1780

          Approximate date of commencement of proposed sale to the public:    From time to time after the effective date of this Registration Statement.

          If the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box.[   ]

          If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check the following box. [ X ]

          If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.[   ] ___________

          If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. [   ] ___________

          If delivery of the prospectus is expected to be made pursuant to Rule 434, please check the following box. [   ]

CALCULATION OF REGISTRATION FEE

Title of each class of securities to Amount to be Proposed maximum Proposed maximum Amount of registration
be registered registered offering price per aggregate offering fee
share(1)

price (1)

Common Stock, par value $0.01 per share (2)

4,100,000 shares $3.87 $15,867,000 $1,846.36

(1)  

Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(c) under the Securities Act of 1933, as amended, based on the average of the high and low prices of the Registrant’s common stock as reported on the Nasdaq National Market on April 8, 2005.


(2)  

Each share of Common Stock being registered pursuant to this registration statement includes a right to purchase one additional share of Common Stock pursuant to the Stockholders’ Rights Plan between the Company and American Stock Transfer & Trust, dated as of April 20, 1995, as amended on April 21, 2003.


        The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended (the “Securities Act”) or until this Registration Statement shall become effective on such date as the Securities and Exchange Commission (the “SEC”), acting pursuant to said Section 8(a), may determine.


The information contained in this prospectus may change. The selling stockholders may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is neither an offer to sell these securities nor a solicitation of an offer to buy these securities in any state where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED APRIL 12, 2005

PROSPECTUS

STAAR Surgical Company

4,100,000 Shares

Common Stock

($0.01 Par Value)

_________________

        This is an offering of common stock of STAAR Surgical Company, or STAAR. All of the shares are being offered by the selling stockholders listed in the section of this prospectus entitled “Selling Stockholders.” We will not receive any of the proceeds from the sale of the 4,100,000 shares being offered by the selling stockholders.

        Our common stock trades on the Nasdaq National Market under the symbol “STAA.” On April 11, 2005, the closing sales price for our common stock on the Nasdaq National Market was $3.95 per share.

_________________

        Investment in our common stock involves a high degree of risk. Please carefully consider the “Risk Factors” beginning on page 4 of this prospectus.

_________________

        Neither the Securities and Exchange Commission, nor any state securities commission, has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

_________________

The date of this prospectus is April __, 2005.


TABLE OF CONTENTS

Page
    Special Note Regarding  
    Forward-Looking Statements
    Prospectus Summary
    Risk Factors
    Use of Proceeds
    Selling Stockholders 16 
    Plan of Distribution 20 
    Legal Matters 22 
    Experts 22 
    Where You Can Find More Information 22 
    Information Incorporated by Reference 23 

        

 

 

 

 

        You should rely only on the information contained in this prospectus or to which we have referred you. We have not authorized anyone else to provide you with different information. This document may be used only where it is legal to sell these securities. The information in this prospectus may only be accurate on the date of this prospectus.

_________________

        Unless the context otherwise requires, the terms “we,” “our,” “us,” the “Company” and “STAAR” refer to STAAR Surgical Company and its subsidiaries.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

        Statements in this prospectus that are not statements of historical fact are forward-looking statements. These statements relate to our future plans, objectives, expectations and intentions. You may generally identify these statements by the use of words such as “expect,” “anticipate,” “intend,” “plan” and similar expressions.

        You should not place undue reliance on our forward-looking statements. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of numerous risks and uncertainties that are beyond our control, including those we discuss in “Risk Factors” and elsewhere in this prospectus, and in our other reports we file with the Securities and Exchange Commission. The forward-looking statements in this prospectus speak only as of the date of this prospectus, and you should not rely on these statements without also considering the risks and uncertainties associated with these statements and our business.


PROSPECTUS SUMMARY

STAAR Surgical Company

        STAAR develops, manufactures and distributes worldwide products used by ophthalmologists and other eye care professionals to improve or correct vision in patients with cataracts, refractive conditions, and glaucoma.

        Cataract Surgery. Our main products are foldable silicone and Collamer® intraocular lenses (“IOLs”) used after minimally invasive small incision cataract extraction. Over the years, we have expanded our range of products for use in cataract surgery to include:

  • the Preloaded Injector, a three-piece silicone IOL preloaded into a single-use disposable injector,
  • toric silicone IOLs to treat astigmatic abnormalities,
  • STAARVISC™II, a viscoelastic material which is used as a tissue protective lubricant and to maintain the shape of the eye during surgery,
  • STAAR SonicWAVE™ Phacoemulsification System, which is used to remove a cataract patient’s cloudy lens and has low energy and high vacuum characteristics, and
  • Cruise Control, a disposable filter which allows for a significantly faster, cleaner phacoemulsification procedure and is compatible with all phacoemulsification equipment utilizing Venturi and peristaltic pump technologies.

        Currently, the majority of our revenues are generated from these products.

        Refractive Surgery. In the area of refractive surgery, we have used our biocompatible Collamer material to develop and manufacture the Visian™ ICL (“ICL”) and the Visian™ TICL (“TICL”) to treat refractive disorders such as myopia (near-sightedness), hyperopia (far-sightedness) and astigmatism. These disorders of vision affect a large proportion of the population. Unlike the intraocular lens (“IOL”), which replaces a cataract patient’s cloudy lens, these products are designed to work with the patient’s natural lens to correct refractive errors. The Company’s goal is to establish the ICL and TICL as the next paradigm shift in refractive surgery, making the products significant revenue generators for the Company over the next four to five years.

        The ICL and TICL have not yet been approved for use in the United States. If approved, we believe that the ICL will have a significant market as an alternative to LASIK and other available refractive surgical procedures and could replace cataract surgery products as STAAR’s largest source of revenue. The ICL is approved for use in the European Union and in Korea and Canada. The TICL is approved for use in the European Union.

        Glaucoma Surgery. We have also developed the AquaFlow™ Collagen Glaucoma Drainage Device (the “Aqua Flow Device”), as an alternative to current methods of treating open-angle glaucoma. The AquaFlow Device is implanted in the sclera (the white of the eye), using a minimally invasive procedure, for the purpose of reducing intraocular pressure.

        Within each of these segments, we also sell other instruments, devices and equipment that we manufacture or that are manufactured by others in the ophthalmic industry. In general, these products complement STAAR’s proprietary product range and allow us to compete more effectively.

        Our executive offices are located at 1911 Walker Avenue, Monrovia, California 91016, and our telephone number is (626) 303-7902. Our website address is www.staar.com. The information on our website is not a part of this prospectus.

The Offering

        The selling stockholders listed in the section of this prospectus entitled “Selling Stockholders” may offer and sell up to 4,100,000 shares of our common stock.

        Under this prospectus, the selling stockholders may sell their shares of common stock in the open market at prevailing market prices or in private transactions at negotiated prices. They may sell the shares directly, or may sell them through underwriters, brokers or dealers. Underwriters, brokers or dealers may receive discounts, concessions or commissions from the selling stockholders or from the purchaser, and this compensation might be in excess of the compensation customary in the type of transaction involved. See the section of this prospectus entitled “Plan of Distribution.”

        We will not receive any proceeds from the potential sale of the 4,100,000 shares offered by the selling stockholders.


RISK FACTORS

        An investment in our common stock involves a high degree of risk. In addition to the other information contained in this prospectus, you should carefully consider the following risks and uncertainties before purchasing our common stock. If any of these risks or uncertainties were to occur, our business, financial condition and operating results could suffer serious harm. In that case, the trading price of our common stock could decline and you could lose all or part of your investment.

Risks Related to Our Business

         We have a history of losses and anticipate future losses.

        We have reported losses in each of the last three fiscal years and have an accumulated deficit of $60.5 million as of December 31, 2004. There can be no assurance that we will report net income in any future period.

          We have only limited working capital.

        Our current sources of working capital are not sufficient to satisfy our anticipated working capital requirements for fiscal 2005.

          We have limited access to credit and could default on the terms of our loan agreement.

        As of December 31, 2004, we have outstanding balances on the credit facility of a European subsidiary of approximately $3.0 million, based on exchange rates on that date. If our losses continue, we risk defaulting on the terms of our credit facility, particularly as it relates to the maintenance of minimum levels of equity and the payment of intercompany receivables.

          We have only limited access to financing.

        Because of our history of losses, there is substantial doubt about our ability to obtain adequate financing on satisfactory terms or at all. Any such financing may involve substantial dilution to existing shareholders.

          We have received a "going concern" opinion from our registered public accounting firm, which may negatively impact our business.

        We have received a report from our independent registered public accounting firm regarding our financial statements for the year ended December 31, 2004 stating that there is substantial doubt about our ability to continue as a going concern.

        The Company expects to continue to experience negative cash flows, similar to those of fiscal 2004, until such time as the issues presented in the FDA Warning Letter of December 22, 2003 and the 483 Observations are resolved and the ICL is approved for sale in the United States. To enhance its ability to continue as a going concern through the year ended December 30, 2005, the Company expects to take the following actions: (1) continue to aggressively address the issues presented in the Warning Letter of December 22, 2003 and the 483 Observations; (2) work closely with the independent sales force and ophthalmic community to reverse the negative perceptions and sales trends of the Company’s existing lines of business; (3) further reduce discretionary spending; (4) seek other sources of funding; and (5) explore other strategic and financial options. However, there can be no assurance as to the availability or terms upon which capital might be obtained or that the Company will be successful in executing its other strategies. In addition, doubt about our ability to continue as a going concern could adversely affect our ability to enter into collaborative relationships with strategic partners and our ability to sell our products and could have a material adverse effect on our business, financial condition and results of operations.

          We have received 483 Inspectional Observations and Warning Letters from the FDA, which until resolved to the satisfaction of the
FDA will continue to delay approval of the ICL and could limit our existing business in the United States.

        On December 29, 2003 and April 26, 2004, we received Warning Letters issued by the FDA. A copy of the first Warning Letter is attached as Exhibit 99.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on January 9, 2004, and a copy of the second Warning Letter is attached as Exhibit 99.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on May 6, 2004.

        On September 23, 2004, the FDA completed a re-audit of our Monrovia, California manufacturing facility. At the conclusion of the audit, the FDA issued a form “FDA 483 Inspectional Observations” described more fully in our Current Report on Form 8-K filed with the Securities and Exchange Commission on September 29, 2004.

        The Warning Letters and 483 Observations have adversely affected our reputation in the ophthalmic industry and our product sales. Until the FDA is satisfied with our response, it is unlikely to grant us approval to market the ICL and the TICL in the United States and may place restrictions on our domestic lines of business.

        Our success depends on the ICL, which has not been approved for use in the United States.

        We have devoted significant resources and management attention to the development and introduction of our ICL and TICL. Management believes that the future success of STAAR depends on the approval of the ICL for sale in the United States by the FDA. The ICL is already approved for use in the European Union and Canada and in parts of Asia. The TICL is approved for use in the European Union. In October 2003, the FDA Ophthalmic Devices Panel recommended that the FDA approve, with conditions, specified uses of the ICL. The FDA has not yet acted on this recommendation, and it could decide to reject the Ophthalmic Devices Panel recommendations. Until the FDA is satisfied with our response to its Warning Letter dated December 22, 2003 and its 483 Observations issued on September 23, 2004, it is unlikely to grant us approval to market the ICL and the TICL in the United States. If the FDA does not grant approval of the ICL, or significantly delays its approval, whether because of the issues contained in the Warning Letter, the 483 Observations or otherwise, our prospects for success will be severely diminished.

        Our future success depends on the successful marketing of the ICL in the United States market.

        Even if it is approved by the FDA for sale in the United States, the ICL will not reach its full sales potential unless we successfully plan and execute its launch and marketing in the United States. This will present new challenges to our sales and marketing staff and to our independent manufacturers’ representatives. In countries where the ICL has been approved to date, our sales have grown steadily, but slowly. In the United States in particular, patients who might benefit from the ICL have already been exposed to a great deal of advertising and publicity about laser refractive surgery, but have little if any awareness of the ICL. As a result, we expect to make extensive use of advertising and promotion targeted to potential patients through providers, and to carefully manage the introduction of the ICL. We do not have significant resources and we cannot predict whether the particular marketing, advertising and promotion strategies we pursue will be as successful as we intend. If we do not successfully market the ICL in the United States, we will not achieve our planned profitability and growth.

        Our core domestic business has suffered declining sales, which sales of new products have only partially offset.

        STAAR pioneered the foldable IOL for use in cataract surgery, and the foldable silicone IOL is one of our largest sources of revenue. Since we introduced the product, however, competitors have introduced IOLs employing a variety of designs and materials. Over the years these products have gradually taken a larger share of the IOL market, while the market share for our IOLs has decreased. In particular, many surgeons now choose lenses made of acrylic material rather than silicone for their typical patients. In an effort to maintain our competitive position we have introduced a new biocompatible lens material, Collamer, to our line of IOLs. We have also introduced new IOL designs, such as the Toric IOL, and have continued to improve and refine the silicone IOL. Sales of these new products, however, have only partially offset declining sales of our silicone IOLs.

        We depend on independent manufacturers' representatives.

        In an effort to manage costs and bring our products to a wider market, we have entered into long-term agreements with certain independent regional manufacturers’ representatives, who introduce our products to eye surgeons and provide the training needed to begin using some of our products. Under our agreements with these representatives, each receives a commission on all of our sales within a specified region, including sales on products we sell into their territories without their assistance. Because they are independent contractors, we have a limited ability to manage these representatives or their employees. In addition, a representative may represent manufacturers other than STAAR, although not in competing products. We have been relying on the independent representatives to introduce our new products like Collamer IOLs, Toric IOLs and the AquaFlow Device, and we will rely on them, in part, to help introduce the ICL if it is approved. If our independent manufacturers’ representatives do not devote sufficient resources to marketing our products, or if they lack the skills or resources to market our new products, our new products will fail to reach their full sales potential and sales of our established products could decline.

        Product recalls have been costly and may be so in the future.

        Medical devices must be manufactured to the highest standards and tolerances, and often incorporate newly developed technology. Despite all efforts to achieve the highest level of quality control and advance testing, from time to time defects or technical flaws in our products may not come to light until after the products are sold or consigned. In those circumstances, we have previously made voluntary recalls of our products. During 2004, we initiated several voluntary recalls of STAAR manufactured produce including 33 lots of IOL cartridges, three lots of injectors, and 529 lenses, and in February 2004, in an action considered a recall but with no requirement for product to be returned to us, we issued a letter to healthcare professionals advising them of the potential for a change in manifest refraction over time in rare cases involving the single-piece Collamer IOL. Similar recalls could take place again. Courts or regulators can also impose mandatory recalls on us, even if we believe our products are safe and effective. Recalls can result in lost sales of the recalled products themselves, and can result in further lost sales while replacement products are manufactured, especially if the replacements must be redesigned. If recalled products have already been implanted, we may bear some or all of the cost of corrective surgery. Recalls may also damage our professional reputation and the reputation of our products. The inconvenience caused by recalls and related interruptions in supply, and the damage to our reputation, could cause some professionals to discontinue using our products.

        We could experience losses due to product liability claims.

        We have in the past been, and continue to be, subject to product liability claims. As part of our risk management policy, we have obtained third-party product liability insurance coverage. Product liability claims against us may exceed the coverage limits of our insurance policies or cause us to record a self-insured loss. A product liability claim in excess of applicable insurance could have a material adverse effect on our business, financial conditions and results of operations. Even if any product liability loss is covered by an insurance policy, these policies have retentions or deductibles that provide that we will not receive insurance proceeds until the losses incurred exceed the amount of those retentions or deductibles. To the extent that any losses are below these retentions or deductibles, we will be responsible for paying these losses. The payment of retentions or deductibles for a significant amount of claims could have a material adverse effect on our business, financial condition, and results of operations.

        Any product liability claim would divert managerial and financial resources and could harm our reputation with customers. We cannot assure you that we will not have product liability claims in the future or that such claims would not have a material adverse effect on our business.

        We compete with much larger companies.

        Our competitors, including Alcon, Advanced Medical Optics, and Bausch & Lomb, have much greater financial resources than we do and some of them have large international markets for a full suite of ophthalmic products. Their greater resources for research, development and marketing, and their greater capacity to offer comprehensive products and equipment to providers, make it difficult for us to compete. We have lost significant market share to some of our competitors.

        Most of our products have single-site manufacturing approvals, exposing us to risks of business interruption.

        We manufacture all of our products either at one of our facilities in California or at our facility in Switzerland. Most of our products are approved for manufacturing only at one of these sites. Before we can use a second manufacturing site for an implantable device we must obtain the approval of regulatory authorities. Because this process is expensive we have generally not sought approvals needed to manufacture at an additional site. If a natural disaster, fire, or other serious business interruption struck one of our manufacturing facilities, it could take a significant amount of time to validate a second site and replace lost product. We could lose customers to competitors, thereby reducing sales, profitability and market share.

        The global nature of our business may result in fluctuations and declines in our sales and profits.

        Our products are sold in more than 45 countries. Revenues from international operations make up a significant portion of our total revenue. For the year ended December 31, 2004 revenues from international operations were 58% of total revenues. The results of operations and the financial position of certain of our offshore operations are reported in the relevant local currencies and then translated into United States dollars at the applicable exchange rates for inclusion in our consolidated financial statements, exposing us to translation risk. In addition, we are exposed to transaction risk because some of our expenses are incurred in a different currency from the currency in which our revenues are received. Our most significant currency exposures are to the Euro, the Swiss Franc, and the Australian dollar. The exchange rates between these and other local currencies and the United States dollar may fluctuate substantially. We have not attempted to offset our exposure to these risks by investing in derivatives or engaging in other hedging transactions. Fluctuations in the value of the United States dollar against other currencies have not had a material adverse effect on our operating margins and profitability in the past.

        Economic, social and political conditions, laws, practices and local customs vary widely among the countries in which we sell our products. Our operations outside of the United States are subject to a number of risks and potential costs, including lower profit margins, less stringent protection of intellectual property and economic, political and social uncertainty in some countries, especially in emerging markets. Our continued success as a global company depends, in part, on our ability to develop and implement policies and strategies that are effective in anticipating and managing these and other risks in the countries where we do business. These and other risks may have a material adverse effect on our operations in any particular country and on our business as a whole. We price some of our products in U.S. dollars, and as a result changes in exchange rates can make our products more expensive in some offshore markets and reduce our revenues. Inflation in emerging markets also makes our products more expensive there and increases the credit risks to which we are exposed.

        We obtain some of the components of our products from a single source, and an interruption in the supply of those components could
reduce our revenue
.

        We obtain some of the components for our products from a single source. For example, only one supplier produces our viscoelastic product. Although we believe we could find alternate supplies for any of these components, the loss or interruption of any of these suppliers could increase costs, reducing our revenue and profitability, or harm our customer relations by delaying product deliveries.

        Our activities involve hazardous materials and emissions and may subject us to environmental liability.

        Our manufacturing, research and development practices involve the controlled use of hazardous materials. We are subject to federal, state, local and foreign laws and regulations in the various jurisdictions in which we have operations governing the use, manufacturing, storage, handling and disposal of these materials and certain waste products. Although we believe that our safety and environmental procedures for handling and disposing of these materials comply with legally prescribed standards, we cannot completely eliminate the risk of accidental contamination or injury from these materials. Remedial environmental actions could require us to incur substantial unexpected costs, which would materially and adversely affect our results of operations. If we were involved in a major environmental accident or found to be in substantial non-compliance with applicable environmental laws, we could be held liable for damages or penalized with fines.

        We risk losses through litigation.

        Since September 1, 2004, multiple class action lawsuits have been filed in the United States District Courts for the Central District of California and the District of New Mexico against the Company and its Chief Executive Officer on behalf of all persons who acquired the Company’s securities during various periods between April 3, 2003 and September 28, 2004. On December 15, 2004, the Court ordered consolidation of the complaints that had been filed in the United States District Court for the Central District of California and directed that the plaintiffs file a consolidated complaint as soon as practicable. The plaintiffs have proposed a stipulation pursuant to which they would file a consolidated amended complaint on or about April 29, 2005. The New Mexico action was voluntarily dismissed on January 28, 2005. The lawsuits generally allege that the defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder, by issuing false and misleading statements regarding intraocular lenses and implantable lenses, and failing timely to disclose significant problems with the lenses, as well as the existence of serious injuries and/or malfunctions attributable to the lenses, thereby artificially inflating the price of the Company’s Common Stock. The plaintiffs generally seek to recover compensatory damages, including interest. While we intend to vigorously defend the consolidated lawsuit, the lawsuit will require significant attention of management and could result in substantial costs and harm our reputation.

        We are currently party to various claims and legal proceedings arising out of the normal course of our business. These claims and legal proceedings relate to contractual rights and obligations, employment matters, and claims of product liability. While we do not believe that any of the claims known to us is likely to have a material adverse effect on our financial condition or results of operations, new claims or unexpected results of existing claims could lead to significant financial harm.

        We depend on key employees.

        We depend on the continued service of our senior management and other key employees. The loss of a key employee could hurt our business. We could be particularly hurt if any key employee or employees went to work for competitors. Our future success depends on our ability to identify, attract, train and motivate other highly skilled personnel. Failure to do so may adversely affect future results.

         We have licensed our technology to our joint venture company and have granted certain rights to the partners that could be exercised
in the event of a change in control of the Company.

        We have granted to the Canon Staar joint venture, a perpetual exclusive license under the Licensed Technology (as defined in the license agreement) to make and sell any products in Japan, and to make any products in China and to sell such products in Japan and China. In addition, we have granted Canon Staar a perpetual non-exclusive license under the Licensed Technology to make and sell any products in the rest of the world. Subject to the approval of the Board of Directors of the joint venture, such licenses may allow the Canon Staar joint venture to sell products in the rest of the world or grant others the right to do so. The term “Licensed Technology” includes any intellectual property owned or controlled by STAAR.

        Upon the occurrence of certain events, including the merger, sale of substantially all of the assets or change in the management of any party to the Canon Staar joint venture, any joint venture partner may have the right to acquire the first party’s interest in the joint venture at book value, without terminating the licenses under the Licensed Technology.

        The joint venture agreement, license agreement and settlement agreement relating to Canon Staar have been filed or incorporated by reference to our Annual Report on Form 10-K for the fiscal year ended December 31, 2004.

Risks Related to the Ophthalmic Products Industry

        If we fail to keep pace with advances in our industry or fail to persuade physicians to adopt the new products we introduce, customers may not buy our products and our revenue may decline.

        Constant development of new technologies and techniques, frequent new product introductions and strong price competition characterize the ophthalmic industry. The first company to introduce a new product or technique to market usually gains a significant competitive advantage. Our future growth depends, in part, on our ability to develop products to treat diseases and disorders of the eye that are more effective, safer, or incorporate emerging technologies better than our competitors’ products. Sales of our existing products may decline rapidly if one of our competitors introduces a substantially superior product, or if we announce a new product of our own. Similarly, if we fail to make sufficient investments in research and development or if we focus on technologies that do not lead to better products, our current and planned products could be surpassed by more effective or advanced products.

        In addition, we must manufacture these products economically and market them successfully by persuading a sufficient number of eye care professionals to use them. For example, glaucoma requires ongoing treatment over a long period of time; thus, many doctors are reluctant to switch a patient to a new treatment if the patient’s current treatment for glaucoma remains effective. This has been a challenge in selling our Aquaflow Device.

        Resources devoted to research and development may not yield new products that achieve commercial success.

        We spent 12.1% of our revenue on research and development (including regulatory and quality assurance expenses) for the year ended December 31, 2004, and we expect to spend between 10-11% of our revenue on an annual basis in the future. Development of new implantable technology, from discovery through testing and registration to initial product launch, is expensive and typically takes from three to seven years. Because of the complexities and uncertainties of ophthalmic research and development, products we are currently developing may not complete the development process or obtain the regulatory approvals required for us to market the products successfully. It is possible that few or none of the products currently under development will become commercially successful.

        Failure of users of our products to obtain adequate reimbursement from third-party payors could limit market acceptance of our
products, which could affect our sales and profits
.

        Many of our products, in particular IOLs and products related to the treatment of glaucoma, are used in procedures that are typically covered by health insurance, HMO plans, Medicare or Medicaid. These third-party payors have recently been trying to contain costs by restricting the types of procedures they reimburse to those viewed as most cost-effective and capping or reducing reimbursement rates. These policies could adversely affect sales and prices of our products. Physicians, hospitals and other health care providers may be reluctant to purchase our products if third-party payors do not adequately reimburse them for the cost of our products and the use of our surgical equipment. For example:

  • Major third-party payors for hospital services, including government insurance plans, Medicare, Medicaid and private health care insurers, have substantially revised their payment methodologies during the last few years, resulting in stricter standards for reimbursement of hospital and outpatient charges for some medical procedures, including cataract procedures and IOLs;
  • Numerous legislative proposals have been considered that, if enacted, would result in major reforms in the United States’ health care system, which could have an adverse effect on our business;
  • Our competitors may reduce the prices of their products, which could result in third-party payors favoring our competitors;
  • There are proposed and existing laws and regulations governing maximum product prices and the profitability of companies in the health care industry; and
  • There have been recent initiatives by third-party payors to challenge the prices charged for medical products. Reductions in the prices for our products in response to these trends could reduce our revenues. Moreover, our products may not be covered in the future by third-party payors, which would also reduce our revenues.

         We are subject to extensive government regulation, which increases our costs and could prevent us from selling our products.

        Government regulations and agency oversight apply to every aspect of our business, including testing, manufacturing, safety and environmental controls, efficacy, labeling, advertising, promotion, record keeping, the sale and distribution of products and samples. We are also subject to government regulation over the prices we charge and the rebates we offer to customers. Complying with government regulation substantially increases the cost of developing, manufacturing and selling our products.

        In the United States, we must obtain approval from the FDA for each product that we market. Competing in the ophthalmic products industry requires us to continuously introduce new or improved products and processes, and to submit these to the FDA for approval. Obtaining FDA approval is a long and expensive process, and approval is never certain. In addition, our operations in the United States are subject to periodic inspection by the FDA. Such inspection may result in the FDA ordering changes in our business practices, which changes could be costly and have a material adverse effect on our business and results of operations. In particular, we received Warning Letters from the FDA on December 29, 2003 and April 26, 2004, and FDA 483 Inspectional Observations on September 23, 2004, requiring us to take corrective action as discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2004.

        Products distributed outside of the United States are also subject to government regulation, which may be equally or more demanding. Our new products could take a significantly longer time than we expect to gain regulatory approval and may never gain approval. If a regulatory authority delays approval of a potentially significant product, the potential sales of the product and its value to us can be substantially reduced. Even if the FDA or another regulatory agency approves a product, the approval may limit the indicated uses of the product, or may otherwise limit our ability to promote, sell and distribute the product, or may require post-marketing studies. If we cannot obtain regulatory approval of our new products, or if the approval is too narrow, we will not be able to market these products, which would eliminate or reduce our potential sales and earnings.

        We depend on proprietary technologies, but may not be able to protect our intellectual property rights adequately.

        We have numerous patents and pending patent applications. We rely on a combination of contractual provisions, confidentiality procedures and patent, trademark, copyright and trade secrecy laws to protect the proprietary aspects of our technology. These legal measures afford limited protection and may not prevent our competitors from gaining access to our intellectual property and proprietary information. Any of our patents may be challenged, invalidated, circumvented or rendered unenforceable. Furthermore, we cannot be certain that any pending patent application held by us will result in an issued patent or that if patents are issued to us, the patents will provide meaningful protection against competitors or competitive technologies. Litigation may be necessary to enforce our intellectual property rights, to protect our trade secrets and to determine the validity and scope of our proprietary rights. Any litigation could result in substantial expense, may reduce our profits and may not adequately protect our intellectual property rights. In addition, we may be exposed to future litigation by third parties based on claims that our products infringe their intellectual property rights. This risk is exacerbated by the fact that the validity and breadth of claims covered by patents in our industry may involve complex legal issues that are not fully resolved.

        Any litigation or claims against us, whether or not successful, could result in substantial costs and harm our reputation. In addition, intellectual property litigation or claims could force us to do one or more of the following: to cease selling or using any of our products that incorporate the challenged intellectual property, which would adversely affect our revenue; to negotiate a license from the holder of the intellectual property right alleged to have been infringed, which license may not be available on reasonable terms, if at all; or to redesign our products to avoid infringing the intellectual property rights of a third party, which may be costly and time-consuming or impossible to accomplish.

        We may not successfully develop and launch replacements for our products that lose patent protection.

        Most of our products are covered by patents that give us a degree of market exclusivity during the term of the patent. We have also earned revenue in the past by licensing some of our patented technology to other ophthalmic companies. The legal life of a patent is 20 years from application. Patents covering our products will expire from this year through the next 20 years. Upon patent expiration, our competitors may introduce products using the same technology. As a result of this possible increase in competition, we may need to charge a lower price in order to maintain sales of our products, which could make these products less profitable. If we fail to develop and successfully launch new products prior to the expiration of patents for our existing products, our sales and profits with respect to those products could decline significantly. We may not be able to develop and successfully launch more advanced replacement products before these and other patents expire.

Risks Related to Ownership of Our Common Stock

        Our Certificate of Incorporation could delay or prevent an acquisition or sale of our company.

        Our Certificate of Incorporation empowers the Board of Directors to establish and issue a class of preferred stock, and to determine the rights, preferences and privileges of the preferred stock. We also have a Stockholders’ Rights Plan, which could discourage a third party from making an offer to acquire us. These provisions give the Board of Directors the ability to deter, discourage or make more difficult a change in control of our company, even if such a change in control would be in the interest of a significant number of our stockholders or if such a change in control would provide our stockholders with a substantial premium for their shares over the then-prevailing market price for the common stock.

Our bylaws contain other provisions that could have an anti-takeover effect, including the following: o only one of the three classes of directors is elected each year; o stockholders have limited ability to remove directors; o stockholders cannot call a special meeting of stockholders; and o stockholders must give advance notice to nominate directors. Anti-takeover provisions of Delaware law could delay or prevent an acquisition of our company.

        We are subject to the anti-takeover provisions of Section 203 of the Delaware General Corporation Law, which regulates corporate acquisitions. These provisions could discourage potential acquisition proposals and could delay or prevent a change in control transaction. They could also have the effect of discouraging others from making tender offers for our Common Stock or preventing changes in our management.

        Future sales of our Common Stock could reduce our stock price.

        Our Board of Directors could issue shares of common or preferred stock, to raise additional capital or for other corporate purposes without stockholder approval. In addition, the Board of Directors could designate and sell a class of preferred stock with preferential rights over the Common Stock with respect to dividends or other distributions. Sales of common or preferred stock could dilute the interest of existing stockholders and reduce the market price of our Common Stock. Even in the absence of such sales, the perception among investors that additional sales of equity securities may take place could reduce the market price of our Common Stock.

        The market price of our Common Stock is likely to be volatile.

        Our stock price has fluctuated widely, ranging from $2.88 to $11.26 during the year ended December 31, 2004. Our stock price could continue to experience significant fluctuations in response to factors such as quarterly variations in operating results, operating results that vary from the expectations of securities analysts and investors, changes in financial estimates, changes in regulatory status, changes in market valuations of competitors, announcements by us or our competitors of a material nature, additions or departures of key personnel, future sales of Common Stock and stock volume fluctuations. Also, general political and economic conditions such as recession or interest rate fluctuations may adversely affect the market price of our stock.

USE OF PROCEEDS

        We will not receive any proceeds from the sale of up to 4,100,000 shares of our common stock being offered by the selling stockholders.


SELLING STOCKHOLDERS

        The following table shows the names of the selling stockholders, and lists the number of shares of our common stock registered for sale by each of them under this prospectus. It also shows the total number of shares of common stock owned by them before and after the offering, and the percentage of our total outstanding shares represented by these amounts. The table assumes that each selling stockholder will sell all of the common stock being offered by this prospectus for their account. However, the selling stockholders have no obligation to sell any of their shares, so we cannot determine the exact number of shares they actually will sell. None of the selling stockholders has had a material relationship with us within the past three years other than as a result of the selling stockholder’s ownership of our securities.

        President Street Fund, L.P., ProMed Management, Inc. and SF Capital Partners, Ltd. are affiliates of registered broker-dealers. We have been informed by each of these selling security holders that they acquired the securities offered by this prospectus for their own account or the accounts of their affiliates in the ordinary course of their business, and that, at the time they acquired the securities, they had no agreement or understanding, direct or indirect, with any person to distribute the securities.

        The table is based on information provided by the selling stockholders, and does not necessarily indicate beneficial ownership for any other purpose. The number of shares of common stock beneficially owned by the selling stockholders is determined in accordance with the rules of the SEC. The term “selling stockholders” includes the stockholders listed below and their transferees, assignees, pledgees, donees or other successors. The percent of beneficial ownership for each selling stockholder is based on 24,790,638 shares of common stock outstanding as of April  11, 2005.

Percent of
Percent of Number of Number of Outstanding
Number of Outstanding Shares of Shares of Shares of
Shares of Shares of Common Stock Common Stock Common Stock
Common Stock Common Stock to be Offered Beneficially Beneficially
Owned Prior Owned Prior Pursuant to Owned After Owned After
Name of Selling Stockholder to Offering (1) to Offering (1) this Prospectus the Offering (2) the Offering (2)
Alpha US Sub Fund V, LLC(3)   58,020   *(4)   43,668   14,352   *  
Andesite Management, L.P.(5)   372,900   1.5%   115,000   257,900   1.0%  
Andover Capital Partners, L.P.(6)   657,287   2.7%   148,800   508,487   2.1%  
Andover Capital Offshore Partners, Ltd.(6)   390,713   1.6%   91,200   299,513   1.2%  
Broadwood Partners, L.P.(7)   1,473,830   6.0%   246,000   1,227,830   5.0%  
Cameron QTIP Trust(8)   105,000   *   20,000   85,000   *  
Cameron Survivors Trust(8)   55,000   *   10,000   45,000   *  
Chad Dunn   51,000   *   15,000   36,000   *  
Craig Drill Capital, L.P.(9)   160,000   *   160,000   --   --  
East Hudson Inc. (BVI) (10)   75,100   *(19)   28,300   46,800   *  
Ivy MA Holdings 3, LLC(3)   213,512   *(4)   160,420   53,092   *  
Lubomir Skrobak   493,210   2.0%   80,000   413,210   1.7%  
Paul Rogan   87,100   *   15,000   72,100   *  
President Street Fund, L.P.(11)   80,000   *   50,000   30,000   *  
ProMed Management, Inc. (12)   735,525   3.0%   300,000   435,525   1.8%  
Seamark Fund, L.P.(13)   235,000   *   100,000   135,000   *  
SF Capital Partners Ltd.(14)   709,276   2.9%   650,000   59,276   *  
SLST Co. Corp(15)   37,575   *   20,000   17,575   *  
Special Situations Cayman Fund, L.P.(16)   371,100   1.5%(17)   215,000   156,100   *  
Special Situations Fund III, L.P.(16)   1,301,096   5.3% (17)   755,000   546,096   2.2%  
Special Situations Private Equity Fund,   497,207   2.0%(17)   289,000   208,027   *  
L.P.(16)  
Symmetry Capital Offshore Fund Ltd. (3)   78,911   *(4)   68,947   9,964   *  
Symmetry Capital Partners L.P. (3)   32,205   *(4)   28,411   3,794   *  
Symmetry Capital Qualified Partners L.P.(3)   205,659   *(4)   180,118   25,541   *  
Symmetry Parallax Partners L.P. (3)   20,941   *(4)   18,436   2,505   *  
The Conus Fund, L.P. (18)   356,730   1.4%(19)   92,300   264,430   1.1%  
The Conus Fund Offshore Ltd.(10)   78,100   *(19)   29,400   48,700   *  
The Conus Fund (QP) L.P.(18)   133,427   *(19)   50,000   83,427   *  
Ursus Capital, L.P.(20)   159,800   *   81,000   78,800   *  
Ursus Offshore Ltd.(20)   62,700   *   29,000   33,700   *  
Willis and Daphne Stephens   46,000   *   10,000   36,000   *  

__________________

* Represents less than 1% of the outstanding shares

(1) The number and percentage of shares beneficially owned is determined in accordance with Rule 13d-3 of the Securities Exchange Act of 1934, as amended, and the information is not necessarily indicative of beneficial ownership for any other purpose. Under Rule 13d-3, the number of shares beneficially owned includes any shares as to which a person has sole or shared voting power or investment power. Shares that a person has the right to acquire within 60 days of the date of this prospectus are included in the shares owned by that person and are treated as outstanding for purposes of calculating the ownership percentage of that person, but not for any other person.

(2) Assumes that all shares being offered by each selling stockholder under this prospectus are sold, that the selling stockholder acquires no additional shares of common stock before the completion of this offering, and that the selling stockholder disposes of no shares of common stock other than those offered under this prospectus.

(3) The management of these funds is directed by Symmetry Capital Management, LLC. As portfolio manager of Symmetry Capital Management, LLC, Kellie Seringer exercises voting and dispositive power over the shares held of record by Alpha US Sub Fund V, LLC, Ivy MA Holdings 3, LLC, Symmetry Capital Offshore Fund Ltd., Symmetry Capital Partners L.P., Symmetry Capital Qualified Partners, L.P. and Symmetry Parallax Partners L.P.

(4) The 609,248 total shares over which Kellie Seringer, as portfolio manager of Symmetry Capital Management, LLC exercises voting and dispositive power comprise approximately 2.6% of the outstanding shares of STAAR Surgical Company.

(5) Includes 77,223 shares held before this offering and 53,408 shares held after this offering by Andesite Life Sciences I, L.P., 55,919 shares held before this offering and 38,674 shares held after this offering by Andesite Life Sciences II, L.P., and 239,758 shares held before this offering and 165,818 shares held after this offering by Andesite Life Sciences Ltd. The management of these funds is directed by Andesite Management, L.P. As managing member of Andesite Management, L.P., Hamilton Mehlman exercises sole voting and investment power over the shares.

(6) David Glancy as managing director of Andover Capital Partners, L.P. and president of Andover Capital Offshore Partners, Ltd., exercises voting and dispositive power over the shares held of record by Andover Capital Partners, L.P. and Andover Capital Offshore Partners, Ltd.

(7) Broadwood Capital, Inc. is the general partner of Broadwood Partners, L.P. As the president of Broadwood Capital, Inc., Neal C. Bradsher exercises voting and dispositive power over the shares held of record by Broadwood Partners, L.P. Mr. Bradsher also beneficially owns 25,900 shares over which he exercises sole voting and dispositive power.

(8) Ralph Cameron, as the trustee of the Cameron QTIP Trust and the Cameron Survivors Trust, exercises voting and dispositive power over the shares held of record by Cameron QTIP Trust and Cameron Survivors Trust.

(9) Craig Drill Capital, LLC is the general partner of Craig Drill Capital, L.P. As the manager of Craig Drill Capital, LLC, Craig A. Drill exercises voting and dispositive power over the shares held of record by Craig Drill Capital, L.P.

(10) Conus Partners, Inc. is the investment manager of East Hudson, Inc. (BVI) and The Conus Fund Offshore Ltd. As managing director of Conus Partners, Inc., Andrew Zacks exercises voting and dispositive power over the shares held of record by East Hudson Inc. (BVI) and The Conus Fund Offshore Ltd.

(11) Francis A. Mlynarczyk, Jr. is the general partner of President Street Fund, L.P., and exercises voting and dispositive power over the shares held of record by President Street Fund, L.P. In addition, Mr. Mlynarczyk, and his wife, Rebecca K. Mlynarczyk, beneficially own a total of 7,500 shares over which they jointly exercise voting and dispositive power. Mr. Mlynarczyk is the chief operating officer of Brimberg & Co., L.P., a registered broker dealer.

(12) Includes 24,614 shares held before this offering and 14,530 shares held after this offering by ProMed Offshore Fund, Ltd., 519,038 shares held before this offering and 307,670 shares held after this offering by ProMed Offshore Fund II, Ltd., 152,558 shares held before this offering and 90,065 shares held after this offering by ProMed Partners, L.P., 39,315 shares held before this offering and 23,260 shares held after this offering by ProMed Partners II, L.P. The management of these funds is directed by ProMed Management, Inc. through the two investment managers, David Musket and Barry Kurokawa. Mr. Musket is a principal of Musket Research Associates, a registered broker dealer, and Mr. Kurokawa is a registered representative of Musket Research Associates.

(13) Seamark Capital, L.P., is the general partner of Seamark Fund, L.P. As the managing partner of Seamark Fund, L.P., John D. Fraser exercises voting and dispositive power of the shares held of record by Seamark Fund, L.P.

(14) Michael A. Roth and Brian J. Stark possess voting and dispositive power over all of the shares owned by SF Capital Partners Ltd. SF Capital Partners Ltd. is affiliated with the registered broker dealers Reliant Trading and Shepherd Trading Limited.

(15) Steven The, as the president of SLST Co. Corp, exercises voting and dispositive power over the shares held of record by SLST Co. Corp.

(16) MGP Advisors Limited (“MGP”) is the general partner of Special Situations Fund III, L.P. AWM Investment Company, Inc. (“AWM”) is the general partner of MGP and the general partner of and investment adviser to Special Situations Cayman Fund, L.P. MG Advisers, LLC (“MG”) is the general partner of and investment adviser to Special Situations Private Equity Fund, L.P. As the principal owners of MGP, AWM, and MG, Austin W. Marxe and David M. Greenhouse exercise voting and dispositive power over the shares held of record by Special Situations Cayman Fund, L.P., Special Situations Fund III, L.P., and Special Situations Private Equity Fund, L.P.

(17) The 2,169,403 total shares over which the persons described in footnote (16) exercise voting and dispositive power comprise approximately 8.8% of the outstanding shares of STAAR Surgical Company.

(18) Conus Capital LLC is the general partner of The Conus Fund, L.P. and The Conus Fund (QP) L.P. As managing member of Conus Capital LLC, Andrew Zacks exercises voting and dispositive power over the shares held of record by The Conus Fund, L.P. and The Conus Fund (QP) L.P.

(19) The 643,357 total shares over which Andrew Zacks, as managing director of Conus Partners, Inc. and as managing member of Conus Capital LLC exercises voting and dispositive power comprise approximately 2.6% of the outstanding shares of STAAR Surgical Company.

(20) Evan Sturza, as the managing director of Ursus Capital L.P. and president of Ursus Offshore Ltd., exercises voting power and dispositive power over the shares held of record by Ursus Capital L.P. and Ursus Offshore Ltd.


PLAN OF DISTRIBUTION

        The selling stockholders and their successors, including their transferees, pledgees or donees, may sell the shares covered by this prospectus from time to time for their own accounts. They will act independently of us in making decisions regarding the timing, manner and size of each sale. They may sell their shares on the Nasdaq National Market or other exchanges, in the over-the-counter market or in privately negotiated transactions. They may sell their shares directly or through underwriters, broker-dealers or agents, who may receive compensation in the form of discounts, concessions, or commissions from the selling stockholders or from the purchasers of the shares. The compensation received by a particular underwriter, broker, dealer or agent might exceed customary commissions.

        The shares of common stock may be sold in one or more transactions at fixed prices, at prevailing market prices at the time of sale, at prices related to the prevailing market prices, at varying prices determined at the time of sale, or at negotiated prices.

        The selling stockholder may sell their shares through any of the following methods or any combination of these methods:

  • purchases by a broker or dealer as a principal and resale by that broker or dealer for its own account under this prospectus;
  • ordinary brokerage transactions and transactions in which the broker solicits purchasers, which may include long or short sales made after the effectiveness of the registration statement of which this prospectus is a part;
  • cross trades or block trades in which the broker or dealer engaged to make the sale will attempt to sell the securities as an agent, but may position and resell a portion of the block as a principal to facilitate the transaction;
  • through the writing of options;
  • in other ways not involving market makers or established trading markets, including direct sales to purchasers or sales made through agents;
  • any combination of the above transactions; or o any other lawful method.

        In addition, any securities covered by this prospectus that qualify for sale in compliance with Rule 144 promulgated under the Securities Act of 1933 may be sold under Rule 144 rather than under this prospectus.

        The selling stockholders may enter into hedging transactions with broker-dealers in connection with distributions of the shares or otherwise. In these transactions, broker-dealers may engage in short sales of common stock in the course of hedging the positions they assume with the selling stockholders.

        The selling stockholders also may sell shares short and redeliver the shares to close out these short positions. The selling stockholders may enter into options or other transactions with broker-dealers that require the delivery to the broker-dealer of the shares. The broker-dealer may then resell or otherwise transfer the shares covered by this prospectus (which may be amended or supplemented to reflect the transaction). The selling stockholders also may loan or pledge the shares to a broker-dealer or another financial institution. If a selling stockholder defaults on the loan or the obligation secured by the pledge, the broker-dealer or institution may sell the shares so loaned or pledged under this prospectus (which may be amended or supplemented to reflect the transaction).

        Broker-dealers or agents may receive compensation in the form of commissions, discounts or concessions from the selling stockholders. Broker-dealers or agents may also receive compensation from the purchasers for whom they act as agents or to whom they sell as principals, or both. Compensation received by a particular broker-dealer might be in excess of customary commissions and will be in amounts to be negotiated in connection with the sale.

        Broker-dealers or agents and any other participating broker-dealers or the selling stockholders may be deemed to be “underwriters” within the meaning of Section 2(11) of the Securities Act in connection with sales of shares. Accordingly, any such commission, discount or concession received by them and any profit on the resale of the shares purchased by them may be deemed to be underwriting discounts or commissions under the Securities Act.

        The selling stockholders have advised us that they have not entered into any agreements, understandings or arrangements with any underwriters or broker-dealers regarding the sale of their securities and that there is no underwriter or coordinating broker acting in connection with the proposed sale of shares by the selling stockholders.

        We have agreed to maintain the effectiveness of the registration statement of which this prospectus is a part until the earliest to occur of the following:

  • April 6, 2007;
  • the date on which all of the selling stockholders can sell the shares offered in this prospectus without registration under Rule 144(k); or
  • the date on which all of shares offered have been sold by the selling stockholders.

        We may suspend the selling stockholders’ rights to resell shares under this prospectus for limited periods if required to do so by regulatory action or because material information or events affecting us are not adequately disclosed in the then available prospectus.

        We have agreed to pay the expenses of registering the shares under the Securities Act, including registration and filing fees, printing expenses, administrative expenses and specified legal and accounting fees. The selling stockholders will bear all discounts, commissions or other amounts payable to underwriters, dealers or agents as well as fees and disbursements for legal counsel retained by any selling stockholder. We have also agreed to indemnify the selling stockholders against liabilities, including certain liabilities under the Securities Act.

        The selling stockholders may agree to indemnify any agent, dealer or broker-dealer that participates in transactions involving sales of shares against liabilities, including liabilities arising under the Securities Act.

        Because the selling stockholders may be deemed to be “underwriters” within the meaning of Section 2(11) of the Securities Act, the selling stockholders will be subject to the prospectus delivery requirements of the Securities Act. If we are required to supplement this prospectus or post-effectively amend the registration statement to disclose a specific plan of distribution of the selling stockholders, the supplement or amendment will describe the particulars of the plan of distribution, including the shares of common stock, purchase price and names of any agent, broker, dealer, or underwriter or arrangements relating to any such entity or applicable commissions.

        Under applicable rules and regulations under the Securities Exchange Act of 1934, as amended, no person engaged in the distribution of the shares may simultaneously engage in market making activities with respect to our common stock for a restricted period before the commencement of the distribution. In addition, the selling stockholders will be subject to applicable provisions of the Securities Exchange Act and the associated rules and regulations under the Securities Exchange Act, including Regulation M, the provisions of which may limit the timing of purchases and sales of the shares by the selling stockholders.

        We will make copies of this prospectus available to the selling stockholders and have informed the selling stockholders of the need to deliver copies of this prospectus to purchasers at or before the time of any sale of the shares.

        Our common stock is traded on the Nasdaq National Market under the symbol “STAA.” The transfer agent for our shares of common stock is American Stock Transfer & Trust Co., 59 Maiden Lane, New York, NY 10038.

LEGAL MATTERS

        The validity of the issuance of the shares of common stock in this offering will be passed on for us by Sheppard, Mullin, Richter & Hampton LLP, Los Angeles, California.

EXPERTS

        The financial statements and schedules incorporated by reference in this prospectus have been audited by BDO Seidman, LLP, an independent registered public accounting firm, to the extent and for the periods set forth in their reports incorporated herein by reference, and are incorporated herein in reliance upon such reports given upon the authority of said firm as experts in auditing and accounting. BDO Seidman's report contains an explanatory paragraph regarding the Company’s ability to continue as a going concern.

WHERE YOU CAN FIND MORE INFORMATION

        Because we are subject to the informational requirements of the Securities Exchange Act, we file reports, proxy statements and other information with the SEC. You may read and copy these reports, proxy statements and other information at the public reference room maintained by the SEC at the following address:

Public Reference Room
450 Fifth Street, N.W.
Washington, D.C. 20549

You may obtain information on the operation of the public reference room by calling the SEC at (800) SEC-0330. In addition, we are required to file electronic versions of those materials with the SEC through the SEC’s EDGAR system. The SEC maintains a web site at http://www.sec.gov, which contains reports, proxy statements and other information regarding registrants that file electronically with the SEC.

        We have filed with the SEC a registration statement on Form S-3 under the Securities Act with respect to the securities offered with this prospectus. This prospectus does not contain all of the information in the registration statement, parts of which we have omitted, as allowed under the rules and regulations of the SEC. You should refer to the registration statement for further information with respect to us and our securities. Statements contained in this prospectus as to the contents of any contract or other document are not necessarily complete and, in each instance, we refer you to the copy of each contract or document filed as an exhibit to the registration statement. Copies of the registration statement, including exhibits, may be inspected without charge at the SEC’s principal office in Washington, D.C., and you may obtain copies from that office on payment of the fees prescribed by the SEC.

        We will furnish without charge to each person to whom a copy of this prospectus is delivered, on written or oral request, a copy of the information that has been incorporated by reference into this prospectus (except exhibits, unless they are specifically incorporated by reference into this prospectus). You should direct any requests for copies to: Investor Relations, STAAR Surgical Company, 1911 Walker Avenue, Monrovia, California 91016, telephone number (626) 303-7902.

INFORMATION INCORPORATED BY REFERENCE

        The Securities and Exchange Commission, or SEC, allows us to “incorporate by reference” in this prospectus the information that we file with the SEC. This means that we can disclose important information by referring the reader to those SEC filings. The information incorporated by reference is considered to be part of this prospectus, and later information we file with the SEC will update and supersede this information. We incorporate by reference the documents listed below and any future filings made with the SEC under Section 13(a), 13(c), 14, or 15(d) of the Securities Exchange Act prior to the termination of the offering:

  • our Annual Report on Form 10-K for our fiscal year ended December 31, 2004;
  • our Current Reports on Form 8-K filed with the SEC on January 21, 2005, February 2, 2005, March 7, 2005 and April 4, 2005;
  • all filings filed by us pursuant to Securities Exchange Act after the date of the original registration statement and prior to effectiveness of the registration statement;
  • The description of our common stock contained in Amendment No. 1 to our registration statement on Form 8-A/A filed with the SEC on April 18, 2003, including any amendment or report filed for the purpose of updating this description; and  
  • The description of our Stockholders’ Rights Plan contained in Amendment No. 1 to our registration statement on Form 8-A/A filed with the SEC on April 18, 2003, including Amendment No. 1 to our Stockholders’ Rights Plan contained in Exhibit 4.7 to our Quarterly Report on Form 10-K for our quarter ended April 4, 2003, including any amendment or report filed for the purpose of updating this description.

        You may obtain copies of those documents from us, free of cost, by contacting us at the address or telephone number provided in “Where You Can Find More Information” immediately above.


PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 14. Other Expenses of Issuance and Distribution.

        The following table sets forth the costs and expenses payable by the Registrant in connection with the sale of common stock being registered. All amounts are estimates except the Securities and Exchange Commission registration fee.

      Securities and Exchange Commission registration fee   $       1,846 .36
      Nasdaq National Market additional listing fee   -
      Accounting fees and expenses   5,000 .00
      Legal fees and expenses   15,000 .00
      Printing and related fees   2,000 .00
      Miscellaneous               500 .00
       
  Total   $     24,346 .36
                                

  

Item 15. Indemnification of Directors and Officers.

        Section 145 of the Delaware General Corporation Law provides that a corporation may indemnify directors and officers as well as other employees and individuals against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement in connection with specified actions, suits or proceedings, whether civil, criminal, administrative or investigative (other than an action by or in the right of the corporation or a derivative action), if they acted in good faith and in a manner they reasonably believed to be in or not opposed to the best interests of the corporation and, with respect to any criminal action or proceedings, had no reasonable cause to believe their conduct was unlawful.

        A similar standard is applicable in the case of derivative actions, except that indemnification only extends to expenses (including attorneys’ fees) actually and reasonably incurred in connection with the defense or settlement of such action, and the statute requires court approval before there can be any indemnification where the person seeking indemnification has been found liable to the corporation. The statute provides that it is not exclusive of other indemnification that may be granted by a corporation’s certificate of incorporation, bylaws, disinterested director vote, stockholder vote, agreement or otherwise.

        As permitted by Section 145 of the Delaware General Corporation Law, Article VIII of our certificate of incorporation, as amended, provides:

 

“The corporation shall to the fullest extent permitted by Section 145 of the Delaware General Corporation Law indemnify all persons whom it may indemnify pursuant thereto.”


        Our by-laws provide for indemnification of officers and directors to the fullest extent permitted by Delaware law. In addition, the Registrant has, and intends in the future to enter into, agreements to provide indemnification for directors and officers in addition to that provided for in the by-laws.

        We maintain an insurance policy pursuant to which our directors and officers are insured, within the limits and subject to the limitations of the policy, against specified expenses in connection with the defense of claims, actions, suits or proceedings, and liabilities which might be imposed as a result of such claims, actions, suits or proceedings, that may be brought against them by reason of their being or having been directors or officers.

        We generally enter into agreements with our executive officers and directors to indemnify them to the fullest extent permitted under the Delaware General Corporation Law.

Item 16. Exhibits.

Exhibit
Number Description of Exhibit
     4.1    Form of Certificate for Common Stock, par value $0.01 per share (incorporated by reference to
          Exhibit 4.1 to Amendment No. 1 to the Company's Registration Statement on Form 8-A/A filed
         with the Commission on April 18, 2003).
     5.1    Opinion of Sheppard, Mullin, Richter & Hampton, LLP
     23.1    Consent of Sheppard, Mullin, Richter & Hampton, LLP (included in its opinion filed as
          Exhibit 5.1)
     23.2    Consent of BDO Seidman, LLP
     24.1    Power of Attorney (See p. II-4)

Item 17. Undertakings.

a.

The undersigned registrant hereby undertakes:

  1. To file, during any period in which offers or sales are being made, a post-effective amendment to this Registration Statement:

  i. To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933, as amended (the “Securities Act”);

  ii. To reflect in the prospectus any facts or events arising after the effective date of this Registration Statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in this Registration Statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and

  iii. To include any material information with respect to the plan of distribution not previously disclosed in this Registration Statement or any material change to such information in this Registration Statement;

  provided, however, that paragraphs (a)(1)(i) and (a)(1)(ii) do not apply if the registration statement is on Form S-3, Form S-8 or Form F-3, and the information required to be included in a post-effective amendment by those paragraphs is contained in periodic reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) that are incorporated by reference in this Registration Statement.

  2. That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

  3. To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

  b. The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act, each filing of the registrant’s annual report pursuant to Section 13(a) or 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in this Registration Statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

  c. Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, executive officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.


SIGNATURES

        Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Monrovia, State of California, on April 12, 2005.

        STAAR SURGICAL COMPANY  
             
       By:   /s/ David Bailey                       
       David Bailey
       President, Chief Executive Officer, Chairman
       and Director (Principal Executive Officer)

POWER OF ATTORNEY FILING
OF REGISTRATION STATEMENT ON FORM S-3

           KNOW ALL BY THESE PRESENTS, that each of the undersigned directors and officers of STAAR Surgical Company, a Delaware corporation (the “Company”), hereby nominate and appoint David Bailey and John Bily, and each of them acting or signing singly, as his or her agents and attorneys-in-fact (the “Agents”), for the undersigned and in the undersigned’s name, place and stead, in any and all capacities (including the undersigned’s capacity as a director or officer of STAAR Surgical Company), to sign a Registration Statement on Form S-3 of STAAR Surgical Company to be filed under the Securities Act of 1933, as amended, for the registration of the resale of 4,100,000 shares of common stock of STAAR Surgical Company by the selling stockholders named herein, and any and all amendments (including post-effective amendments) to such Registration Statement, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto the Agents full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as the undersigned might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent, or his substitutes, may lawfully cause to be done by virtue hereof.

        This Power of Attorney shall remain in full force and effect until revoked or superseded by written notice filed with the SEC.


        Pursuant to the requirements of the Securities Act of 1933, this Registration Statement has been signed below by the following persons in the capacities and on the dates indicated.

 
Signature Title Date
  /s/ David Bailey                     President, Chief Executive Officer, April 12, 2005
David Bailey Chairman and Director (Principal    
     Executive Officer)    
        
  /s/ John Bily                          Chief Financial Officer and Chief April 12, 2005
John Bily Accounting Officer (Principal    
     Financial and Accounting Officer)    
        
  /s/ Donald Duffy                  Director April 12, 2005
Donald Duffy         
             
  /s/ Volker D. Anhaeusser   Director April 12, 2005
Dr. Volker D. Anhaeusser         
             
  /s/ David Schlotterbeck     Director April 12, 2005
David Schlotterbeck         
             
  /s/ David Morrison             Director April 12, 2005
David Morrison         
             

EXHIBIT INDEX

Exhibit
Number Description of Exhibit
     4.1    Form of Certificate for Common Stock, par value $0.01 per share (incorporated by reference to
          Exhibit 4.1 to Amendment No. 1 to the Company's Registration Statement on Form 8-A/A filed
         with the Commission on April 18, 2003).
     5.1     Opinion of Sheppard, Mullin, Richter & Hampton, LLP.
     23.1    Consent of Sheppard, Mullin, Richter & Hampton, LLP (included in its opinion filed as
          Exhibit 5.1)
     23.2     Consent of BDO Seidman, LLP
     24.1    Power of Attorney (See p. II-4)