UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): September 23, 2004
STAAR SURGICAL COMPANY
(Exact name of registrant as specified in its charter)
Delaware 0-11634 95-3797439
(State or other jurisdiction (Commission File Number) (I.R.S. Employer Identification No.)
of incorporation or organization)
1911 Walker Avenue, Monrovia, California 91016
(Address of principal executive offices) (Zip Code)
(626) 303-7902
(Registrant's telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange
Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange
Act (17 CFR 240.13e-4(c))
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ITEM 5.02. DEPARTURE OF DIRECTORS OR PRINCIPAL OFFICERS; ELECTION OF
DIRECTORS; APPOINTMENT OF PRINCIPAL OFFICERS.
On September 25, 2004, John R. Gilbert resigned from the Board of
Directors for personal reasons, including a death and a serious illness in his
family. The Company has been advised that Mr. Gilbert has resigned his
directorship in each company which has a class of securities registered pursuant
to Section 12 of the Securities Exchange Act of 1934, as amended (the "Exchange
Act"), or subject to the requirements of Section 15(d) of the Exchange Act.
ITEM 8.01. OTHER EVENTS.
As previously announced, the Company received a warning letter from
the United States Food and Drug Administration (the "FDA") on December 29, 2003
(the "Warning Letter"), following the FDA's inspection of the Company's facility
in Monrovia, California. A copy of the Warning Letter is attached as Exhibit
99.1 to the Company's Current Report on Form 8-K filed with the Securities and
Exchange Commission on January 9, 2004.
The Company engaged the services of Quintiles Consulting
("Quintiles"), a well regarded consulting organization that specializes in FDA
related compliance matters, to assist it in correcting the issues raised in the
Warning Letter. The Company, with Quintiles' help, has assessed the state of its
quality system in light of the FDA's concerns and has developed an improvement
plan. This plan was submitted to the FDA. It provided details of a systematic
approach for reviewing and improving all of the Company's quality system
procedures. The following are some of the actions that the Company has taken in
consultation with Quintiles:
- conducted a retrospective review of complaint files from the
last three years and conducted root cause analysis;
- implemented more rigorous quality processes for complaint
investigation, root cause analysis, trend analysis and
reporting;
- submitted a quality system improvement plan to the FDA that
details a systematic approach for reviewing and improving all
of the Company's quality systems procedures;
- strengthened the expertise in several critical business
functions, including quality, clinical, regulatory,
manufacturing and research and development. Specifically, the
Company expanded the Complaint Handling staff, hiring an M.D.
to manage the department, and hired a Vice President of
Research and Development, a Vice President of Regulatory
Affairs/Quality Assurance, and various quality and
manufacturing engineering employees;
- successfully completed the FDA's pre-approval inspection of
the Company's Nidau, Switzerland manufacturing facility with
no observations; and
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- re-engineered several key quality systems including failure
investigation, root cause analysis, complaint handling and
medical device reporting, clinical systems, management
review, corrective and preventive action, trending and
analysis practices, and validation.
On July 28, 2004, the FDA commenced an inspection of the Monrovia
facility to determine the progress of the Company's corrective actions. On
September 23, 2004, the FDA completed the inspection and issued a form "FDA 483
Inspectional Observations" (the "FDA 483"). The FDA 483 contains observations
that, in the opinion of the FDA investigators, represent deviations from the
FDA's regulatory requirements. Observations listed on the FDA 483 do not
necessarily represent a final FDA determination as to the state of the Company's
compliance. The FDA 483 contains 36 observations addressing the following areas:
production and process controls, corrective and preventative action, quality
system requirements, statistical techniques, complaint handling system, medical
device reporting, design controls, acceptance criteria, and document controls
and records.
During the meeting with the FDA at the conclusion of the inspection,
the Company provided an initial response to each of the observations. In
response to some of the observations, the Company provided evidence, and the FDA
verified, that corrective action had been taken. With respect to other
observations, the Company provided evidence of corrective action which requires
verification by the FDA. In addition, the Company promised to undertake
corrective action with respect to some of the observations, and gave no response
to other observations pending further evaluation.
The Company is preparing a written response to the FDA 483 to be
submitted as soon as practicable. Until the FDA is satisfied with the adequacy
of the Company's corrective action, it may take further actions which could
include conducting another inspection, seizure of the Company's products,
injunction of the Monrovia facility to compel compliance (which may include
suspension of production operations and/or recall of products), or other
actions. Such actions could have a material adverse effect on the Company's
established lines of business, results of operations and liquidity. Furthermore,
until the FDA is satisfied with the Company's response, it is unlikely to grant
the Company approval to market the ICL in the United States.
The Company is not able to predict whether the FDA will conclude
that the Company's corrective actions to date or those to be included in its
response to the FDA 483 satisfactorily resolve its concerns. Nor can the Company
predict the likelihood, nature of, or timing of any additional action by the FDA
or the impact of the FDA 483 or any other FDA action on the Company's
established lines of business, results of the operations or liquidity or the
approval of the ICL for the United States market. The Company does not believe
that it will receive approval of the ICL before the October 22, 2004 meeting of
the American Academy of Ophthalmologists.
The business of the Company is subject to numerous risks and
uncertainties that are beyond its control, including, but not limited to, those
set forth above and in the other reports filed by the Company with the
Securities and Exchange Commission. Such risks and
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uncertainties could have a material adverse effect on the Company's business,
financial condition, operating results and cash flows.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
STAAR SURGICAL COMPANY
Date: September 28, 2004 By /s/ John Bily
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John Bily,
Chief Financial Officer
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