| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human ServicesWARNING LETTER
FEB 12 2010
VIA FEDERAL EXPRESS
Ms. Nancy L. Rust
Patient Care Manager
LCA Vision Inc. and LasikPlus Vision Center-Cincinnati
7840 Montgomery Road
Cincinnati, Ohio 45236
Dear Ms. Rust:
During an inspection of your corporate facility located in Cincinnati, Ohio, on June 16-19, 23-24 and August 5, 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, Inspectional 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 contract.
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 our products into compliance.
Sincerely yours,
/S/
Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health
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