FDA WARNING_LETTER - Vision Care Holdings, Inc dba The LASIK Vision Institute - July 13, 2009

During an inspection on June 22 and July 13, 2009, Vision Care Holdings, Inc. dba The LASIK Vision Institute in Pittsburgh, Pennsylvania, was identified as a medical device user facility subject to Medical Device Reporting (MDR) regulations (21 CFR Part 803). The ophthalmic laser used for LASIK procedures is a medical device under section 201(h) of the Federal Food, Drug, and Cosmetic Act.

The inspection revealed non-conformance with MDR regulations. Although no FDA Form 483 was issued, violations were discussed with management. The LASIK devices are considered misbranded under section 502(t)(2) of the Act because the firm failed to furnish required information under section 519 and 21 CFR Part 803.

A significant deviation noted was the "Failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17." The FDA requires prompt corrective action to prevent regulatory actions, including seizure, injunction, and/or civil money penalties. Other federal agencies may also consider this Warning Letter when awarding contracts.

The firm must notify the FDA in writing within fifteen working days of receiving the letter, detailing specific corrective steps, preventative measures, and documentation. If corrections are phased, a timetable is required. The response should be sent to Ronald Swann, Branch Chief, Dental, ENT,