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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

LasikPlus Vision Center Lakewood, CO

   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  10903 New Hampshire Avenue
Silver Spring, MD 20993

OCT 09 2009

WARNING LETTER

VIA FEDERAL EXPRESS

Ms. Camille N. Joseph
Center Director
LasikPlus Vision Center
7440 W. Alaska Drive
Lakewood, Colorado 80226


Dear Ms. Joseph:


During an inspection of your facility located in Lakewood, Colorado on July 14,2009, an
investigator from the United States Food and Drug Administration (FDA) determined that your
firm is a medical device user facility and is subject to the statutory reporting requirements of the
Medical Device Reporting (MDR) regulation, found at Title 21, Code of Federal Regulations
(CFR) Part 803.

The ophthalmic laser used at your facility to perform Laser-Assisted In Situ Keratomileusis
(LASIK) procedures is a medical device under section 201(h) of the Federal Food, Drug, and
Cosmetic Act (the Act), 21 U.S.C. 321(h). This product is a device because it is intended for use
in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention
of disease, or to affect the structure or function of the body.

The inspection revealed that your facility is not in conformance with the MDR regulations found
at 21 CFR Part 803. Although no Form FDA 483, lnspectional Observations, was issued to your
firm, the observed violations were reported to you and formally discussed with your firm's
management at the close of the inspection. The LASIK devices used at your facility are
misbranded under section 502(1)(2) of the Act, 21 U.S.C. 352(1)(2), in that your firm failed or
refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803. Significant deviations include, but are not limited to, the following:

Failure to develop, maintain, and implement written MDR procedures as required by 21
CFR 803.17.

You should take prompt action to correct the violation addressed in this letter. Failure to
promptly correct this violation may result in regulatory action being initiated by FDA without
further notice. These actions include, but arc not limited to, seizure, injunction, and/or civil
money penalties. Also, other Federal Agencies may take this Warning Letter into account when
considering the award of contracts.

Please notify this office in writing within fifteen working days from the date you receive this
letter of the specific steps you have taken to correct the noted violations. including an
explanation of how you plan to prevent these violation, or similar violation, from occurring
again. Include documentation of the corrective action you have taken. If your planned
corrections will occur over time, please include a timetable for implementation of those
corrections.

Your response should be sent to: Ronald Swann, Branch Chief, Dental, ENT, and Ophthalmic
Devices, 10903 New Hampshire Avenue, Silver Spring, MD 20993. If you have any questions
about the content of this letter please contact Mr. Swann at (301) 796-5770.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations
at your facility. It is your responsibility to ensure compliance with applicable laws and
regulations administered by FDA. The specific violation noted in this letter may be symptomatic
of serious problems in your firm and corporate-level reporting systems. You should investigate
and determine the causes of the violation, and take prompt actions to correct the violation and to bring your products into compliance.

Sincerely yours,

/S/

Timothy A. Ulatoski
Director
Office of Compliance
Center for Devices and
Radiological Health