FDA WARNING_LETTER - The Lasik Vision Institute - August 12, 2009

The FDA inspected Lasik Vision Institute in Burlington, Massachusetts, on June 22 and August 12, 2009, identifying it 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. The inspection revealed the facility was not in conformance with MDR regulations. Specifically, the LASIK devices are considered misbranded under section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act because the firm failed to furnish required material or information under section 519 of the Act and 21 CFR Part 803. A significant deviation identified was the failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. The FDA requires prompt corrective action, including a written response within fifteen working days detailing specific steps taken, how similar violations will be prevented, and a timetable for implementation. Failure to correct these violations could lead to regulatory actions such as seizure, injunction, and civil money penalties, and may impact federal contracts. The letter emphasizes the firm's responsibility for overall compliance and investigating root causes.