Lasik Vision Institute 2/12/10

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

FEB 12 2010

WARNING LETTER

VIA FEDERAL EXPRESS

Ms. Carrianne Bushey
General Manager
Lasik Vision Institute
50 Mall Road,
Burlington, Massachusetts 01803-4522

Dear Ms. Bushey:

During an inspection of your facility located in Burlington, Massachusetts, on June 22, 2009 and August 12,2009, 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 the use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended 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(t)(2) of the Act, 21 U.S.C. 352(t)(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 the FDA without further notice. These actions include, but are 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 violation, including an explanation of how you plan to prevent this violation, or similar violations, 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,

/S/
Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health

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