Exhibit 99.2
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APPROVED BY: David Bailey
President & CEO
626-303-7902
CONTACT: Investors Media
EVC Group EVC Group
Douglas Sherk, 415-896-6820 Sheryl Seapy, 415-272-3323
Jennifer Cohn, 415-896-6820
FOR IMMEDIATE RELEASE
STAAR SURGICAL AGGRESSIVELY PURSUING CORRECTION OF ISSUES
CITED IN FDA WARNING LETTER
Immaterial Costs Expected to be Incurred to Implement Corrective Actions
Company to Host Conference Call 12:00 P.M. EST January 7, 2004
MONROVIA, CA---January 7, 2004---STAAR Surgical Company (Nasdaq: STAA) today
announced that it is aggressively pursuing corrective actions to remedy issues
cited in a Warning Letter received by the Company on December 29, 2003 from the
U.S. Food and Drug Administration (FDA). The Company is committed to invest the
resources required to do whatever is necessary to implement the corrective
actions identified. At this point in time, management believes the costs that
will be incurred to implement corrective actions to successfully resolve these
issues will not be material. The Company is cooperating fully with the FDA to
address their concerns.
The issues cited in the Warning Letter were identified during inspection audits
conducted by the FDA Office of Compliance between August 12 and September 4 as
part of the approval process for STAAR's Implantable Contact Lens (ICL). The
first issue identified by the inspections determined that STAAR has not
developed maintained and implemented written Medical Device Reporting (MDR)
procedures for reports of serious injuries attributed to the Company's
cartridges and injectors. Specific instances mentioned in the FDA's letter
concerned only the IOL lens. The second issue concerned the procedure for
approving an outside testing laboratory. This procedure did not assure that the
methods used to test raw materials and finished devices by that testing
laboratory had been validated. The letter also stated that "no premarket
submissions for Class III devices to which the Quality system regulation
deficiencies are reasonably related would be cleared until the violations have
been corrected."
"We believe that the actions required to correct the issues cited by the FDA in
its Warning Letter can be successfully resolved in a reasonable time-frame and
we are cooperating fully with the FDA to implement corrective actions," said
David Bailey, President and Chief Executive Officer of STAAR Surgical. "At this
point in time, we don't believe the costs that will be incurred to implement the
correction actions will be material and we are confident about our ability to
earn FDA approval for the ICL. The complaints discussed on the first point of
the FDA warning letter (diopter shift, cloudy vision, blurred vision and
capsular tears) were reported for Intraocular Lenses used in cataract surgery
and not in ICL for Myopia being considered for approval. The Company is
extremely confident that all of the ICL related complaints in the US FDA Study
have been accurately and completely reported to the FDA, and were disclosed
prior to the October 3, 2003 panel meeting."
Conference Call
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The Company will host a conference call and webcast January 7, 2004 at 12:00
p.m. EST to discuss this recent development. The dial-in number for the
conference call is 800-219-6110 for domestic participants and 303-262-2050 for
international participants.
About STAAR Surgical
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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
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All statements in this press release that are not statements of historical fact
are forward-looking statements, including any projections of successfully
correcting issues identified by the FDA in its Warning Letter, 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.
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