FDA Determines that ICL(TM) PMA for Myopia in the Range of -3.0 to -20.0
                       Diopters is Suitable for Filing

MONROVIA, Calif., July 1 /PRNewswire-FirstCall/ -- STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, announced today that the Pre-Market Approval Application (PMA) for its Implantable Contact Lens (ICL) has been accepted for substantive review by the U.S. Food and Drug Administration (FDA) and has been granted an expedited review status. The official filing date for the ICL PMA was May 8, 2003.

According to the FDA Center for Devices and Radiological Health (CDRH) guidance document that is available at www.fda.gov/cdrh/modact/expedite.pdf, "Expedited review will generally be considered when a device offers a potential for clinically meaningful benefit as compared to the existing alternatives ... or when the new medical device promises to provide a revolutionary advance ... over currently available alternative modalities." In notifying the Company of the expedited review, the FDA said, "We believe that the Collamer(TM) Implantable Contact Lens (ICL) for Myopia may provide a clinically meaningful advantage over existing technology in terms of increased effectiveness for patients with high myopia."

"Although the granting of expedited review status does not guarantee that the application will be approved it does mean that the ICL will receive a priority review," said Helene Lamielle, M.D., vice president of Scientific Affairs at STAAR. "The ICL's application will be reviewed before other pending applications and placed at the beginning of the appropriate review queue," she said.

"We are delighted that the FDA has accepted the PMA for our ICL so quickly after our submission," said David Bailey, president and CEO of STAAR Surgical. "The acceptance of this third and final module of our PMA brings us one step closer to commercialization of the ICL in the U.S., and we continue to believe we will be the first to market this technology in the United States. We have always asserted that the ICL would represent the next paradigm shift in refractive surgery and consider the granting of expedited review status by the FDA an underscore of this belief."

The STAAR ICL is a phakic refractive lens that provides state-of-the-art treatment for the most prevalent sight deficiencies -- near-sightedness, far-sightedness and astigmatism. The current submission is for the correction of myopia, or near-sightedness, in the range of -3.0D to -20.0D. The Company is presently enrolling candidates in the clinical trial for the hyperopic ICL as well as the Toric ICL, which reduces myopia combined with astigmatism.

STAAR's ICL has received CE Marking, is approved for sale in 37 countries and has been implanted in more than 30,000 eyes worldwide. If granted approval by the FDA, STAAR will be allowed to market the ICL in the United States for the reduction of near-sightedness.

About STAAR Surgical

STAAR Surgical is a leader in the development, manufacture and marketing of minimally invasive ophthalmic products employing proprietary technologies. STAAR's products are used by ophthalmic surgeons and include the revolutionary Implantable Contact Lens as well as innovative products designed to improve patient outcomes for cataracts and glaucoma.

Safe Harbor

All statements in this press release that are not statements of historical fact are forward-looking statements, including any projections of earnings, revenue, or other financial items, any statements of the plans, strategies, and objectives of management for future operations, any statements concerning proposed new products and government approval of new products, services or developments, any statements regarding future economic conditions or performance, statements of belief and any statements of assumptions underlying any of the foregoing. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties include the need to obtain regulatory approval for new products, acceptance of new products by medical practitioners and consumers, the rapid pace of technological change in the ophthalmic industry, general domestic and international economic conditions, and other factors beyond the control of STAAR Surgical Company, including those detailed from time to time in STAAR Surgical Company's reports filed with the Securities and Exchange Commission. STAAR Surgical Company assumes no obligation and does not intend to update these forward-looking statements.

    CONTACT:   Investors                          Media
          EVC Group                          EVC Group
          Douglas Sherk, 415-659-2285        Sheryl Seapy, 415-272-3323
          Jennifer Cohn, 415-659-2289


SOURCE  STAAR Surgical Company
    -0-                             07/01/2003
    /CONTACT:  investors, Douglas Sherk, +1-415-659-2285, or Jennifer Cohn,
+1-415-659-2289, or media, Sheryl Seapy, +1-415-272-3323, all of EVC Group for
STAAR Surgical/
    /Web site:  http://www.staar.com /
    (STAA)

CO:  STAAR Surgical Company
ST:  California
IN:  HEA MTC
SU:  SVY



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2287 07/01/2003 06:30 EDT http://www.prnewswire.com