FDA WARNING_LETTER - TLC Vision Corporation - August 06, 2009

On August 6, 2009, the FDA inspected TLC Vision Corporation dba TLC Plymouth Meeting, identifying it as a medical device user facility subject to Medical Device Reporting (MDR) regulations (21 CFR Part 803). The facility uses ophthalmic lasers for LASIK procedures, which are considered medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act.

The inspection revealed non-conformance with MDR regulations, specifically that the LASIK devices are misbranded under section 502(t)(2) of the Act because the firm failed to furnish required material or information per 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. Although no FDA Form 483 was issued, these violations were discussed with management.

The FDA requires prompt corrective action to prevent regulatory actions such as seizure, injunction, and/or civil money penalties. The firm must notify the FDA in writing within fifteen working days of receiving the letter, detailing specific corrective steps, how similar violations will be prevented, and a timetable for implementation if corrections are ongoing. Documentation of corrective actions must be included. The response should be sent to Ronald Swann, Branch Chief, Dental, ENT, and Ophthalmic Devices. The letter also states that this is not