MONROVIA, Calif., Jan 20, 2004 /PRNewswire-FirstCall via COMTEX/ -- STAAR Surgical Company (Nasdaq: STAA) today provided an overview of its meeting with the U.S. Food and Drug Administration (FDA) held on Wednesday, January 14, 2004. As the Company communicated during its conference call on January 7, the meeting was scheduled to discuss the Warning Letter received by STAAR Surgical on December 29, 2003.

According to David Bailey, Chairman and CEO of STAAR Surgical, the Company provided a written response to the Warning Letter within the required 15 business days and just prior to the Wednesday meeting. The meeting with the FDA, which was attended by Mr. Bailey and senior members of STAAR's management team, lasted approximately two hours and included attendees from various branches of the agency, including the Los Angeles office that carried out the inspections resulting in the issuance of the Warning Letter. During the meeting STAAR made a formal presentation of its response to the Warning Letter including a review of the action plan that had already been implemented to address the various issues raised by the FDA and a review of the Company's overall quality system.

"We believe the meeting was a very productive exchange that communicated to the FDA the Company's commitment to aggressively address the FDA's issues and provided us with valuable input on how to fine tune our action plan," said Mr. Bailey. "We discussed with the agency the deficiencies in complaint handling and reporting of MDRs related to the Company's IOLs, shared with the agency the findings of some of our root cause analysis into the IOL product complaints highlighted in the letter, and reviewed the results of our efforts since receiving the letter on December 29th. While we have much work to do before we request a re-audit, I am pleased with the progress to date."

Mr. Bailey noted that STAAR will continue to implement corrective actions for the issues raised in the Warning Letter while awaiting response from the agency to STAAR's corrective action plan. The Company currently has no indication when it will receive the response to the plan. "As we discussed during our conference call on January 7th, we must resolve the issues cited in the Warning Letter to the agency's satisfaction before approval of any new device, such as the ICL, can be granted. Returning to compliance with the FDA's guidelines is our number one priority. The issues raised in the Warning Letter clearly put a major strain on our original goal of receiving approval for the ICL four to six months after the FDA Panel meeting on October 3, 2003. Based on Wednesday's meeting, we continue to believe our original goal is possible to achieve, but much has to be accomplished for us to be successful. We will not request re-audit until we are confident we have taken all of the corrective actions necessary in all areas of our quality system. When we are ready for a re-audit, our expedited review status of the ICL will result in the local agency giving priority to the re-audit. We will issue a news release when the Company receives response to the Company's corrective action plan," Mr. Bailey concluded.

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(TM) as well as innovative products designed to improve patient outcomes for cataracts and glaucoma. 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.

Safe Harbor

All statements in this press release that are not statements of historical fact are forward-looking statements, including any statement concerning the likelihood of, or the time necessary to successfully correct the issues identified by the FDA in its Warning Letter, any statement of the likelihood of, or time necessary to successfully obtain FDA approval of the ICL, 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 to update these forward-looking statements and does intend to do so.

    CONTACT:
     David Bailey
     President & CEO
     626-303-7902

     Investors                               Media
     EVC Group                               EVC Group
     Douglas Sherk, 415-896-6820             Sheryl Seapy,
     Jennifer Beugelmans, 415-896-6820       415-272-3323

SOURCE STAAR Surgical Company

David Bailey, President & CEO of STAAR Surgical Company,
+1-626-303-7902; or investors, Douglas Sherk, +1-415-896-6820, or Jennifer
Beugelmans, +1-415-896-6820, or media, Sheryl Seapy, +1-415-272-3323, all of
EVC Group for STAAR Surgical Company

http://www.staar.com