Exhibit 99.1
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[FDA Letterhead]
Department of Health and Human Services Public Health Service
Food and Drug Administration
Los Angeles District
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19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
WARNING LETTER
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CERTIFIED MAIL
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RETURN RECEIPT REQUESTED
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December 22, 2003
W/L 16-04
Mr. David Bailey
President and CEO
Staar Surgical Company
19 11 Walker Avenue
Monrovia, California 91016
Dear Mr. Bailey:
During an inspection of your establishment located in Monrovia, California, on
August 12 - September 4, 2003, our Investigators determined that your firm
manufactures the Staar Surgical Implantable Contact Lens (ICL). ICL is a device
as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the
Act).
The above-stated inspection revealed that this device is adulterated under
section 501(h) of the Act, in that the methods used in, or the facilities or
controls used for, its manufacture, packing, storage, or installation are not in
conformance with the Current Good Manufacturing Practice (CGMP) requirements for
medical devices which are set forth in the Quality System regulation, as
specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant
deviations include, but are not limited to, the following:
1. Failure to ensure that any complaint involving the possible failure of a
device, labeling, or packaging to meet any of its specifications shall be
reviewed, evaluated, and investigated, as required by 21 CFR 820.198(c).
Specifically, your firm failed to perform root cause analysis of
complaints involving diopter shift, blurred vision, cloudy vision, and
posterior capsule tears.
2. Failure to establish and maintain procedures for acceptance of incoming
product, as required by 21 CFR 8 820.80(b). Specifically, your firm's
procedure for approving a vendor (test laboratory) does not assure that
the methods used to test raw materials and finished devices have been
validated.
The above-stated inspection also revealed that your device is misbranded under
section 502(t)(2) of the Act, in that your firm failed or refused to furnish
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material or information required by or under section 519 respecting the device.
Specifically, your firm failed to develop, maintain, and implement written MDR
procedures, as required by 21 CFR 0 803.17(a)(1). For example, there were
reports to your firm of serious injuries or malfunctions likely to cause or
contribute to serious injuries attributed to the IOL/ICL, cartridges and
injectors, and your firm failed to report these events to FDA. In one case, a
physician had to perform a vitrectomy on a patient after the lens delivery
system failed. In another incident, a physician had to suture a patient after
the cartridge failed. Your company had knowledge of these serious injuries but
failed to forward the information to the FDA. This letter is not intended to be
an all-inclusive list of deficiencies at your facility. It is your
responsibility to ensure adherence to each requirement of the Act and
regulations.
The specific violations noted in this letter and in the FDA 483 issued at the
close of the inspection may be symptomatic of serious underlying problems in
your firm's manufacturing and quality assurance systems. You are responsible for
investigating and determining the causes of the violations identified by the
FDA. You also must promptly initiate permanent corrective and preventive action
on your Quality System.
Federal agencies are advised of the issuance of all Warning Letters about
devices so that they may take this information into account when considering the
award of contracts. Additionally, no premarket submissions for Class III devices
to which the Quality System regulation deficiencies are reasonably related will
be cleared until the violations have been corrected. Also, no requests for
Certificates to Foreign Governments will be approved until the violations
related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly
correct these deviations may result in regulatory action being initiated by the
Food and Drug Administration without further notice. These actions include, but
are not limited to, seizure, injunction, and/or civil money penalties.
We received a response from [redacted], dated September 29, 2003, concerning the
investigator's observations noted on the FDA 483. It appears that your firm's
response to the MDR observations is inadequate. We believe that the information
contained in your firm's record reasonably suggests that Staar Surgical Company
received information that should have been reported to FDA as MDRs. In
particular, we believe that complaints of lens tears, posterior capsule tears
without vitrectomy, and cartridge and injector problems upon lens delivery
should have been reported to FDA as MDRs pursuant to 21 CFR 803.3(r).
The September 29th response to the GMP observations noted on the FDA 483 may be
adequate. However, a follow-up inspection will be required to assure that
corrections have been implemented. After the FDA re-inspection has taken place,
and the implementation of your corrections has been verified, you will be
notified whether your corrections are adequate.
Please notify this office in writing within fifteen (15) working days of receipt
of this letter of the specific steps you have taken to correct the noted
violations, including an explanation of each step being taken to prevent the
recurrence of similar violations. Your response should include both the steps
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Staar Surgical is taking to rectify its MDR reporting procedures, as well as the
steps the company is taking to report promptly all prior unreported events that
fall within the reporting requirements of section 519 of the Act. If corrective
action cannot be completed within 15 working days, state the reason for the
delay and the time within which the corrections will be completed.
Your written response should be sent to:
Director of Compliance
U.S. Food and Drug Administration
19900 MacArthur Boulevard, Suite 300
Irvine, California 926 12
If you have any questions regarding this letter, please contact Ms. MaryLynn
Datoc, Compliance Officer, at (949)608-4428.
Sincerely yours,
/s/ Alonza E. Cruse
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Alonza E. Cruse
District Director
Los Angeles District Office