FDA WARNING_LETTER - Vision Care Holdings, LLC - January 11, 2009

During an inspection from January 6-11, 2009, FDA determined that Vision Care Holding, LLC dba Lasik Vision Institute, a medical device user facility, failed to comply with Medical Device Reporting (MDR) regulations (21 CFR Part 803). The ophthalmic laser used for LASIK procedures at the facility is a medical device.

The inspection revealed the facility is not in conformance with MDR regulations, leading to a Form FDA 483. The LASIK devices are considered misbranded under section 502(t)(2) of the Act (21 U.S.C. 352(t)(2)) because the firm failed to provide required information under section 519 of the Act (21 U.S.C. 360i) 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 to prevent regulatory actions such as seizure, injunction, or civil money penalties. The firm must respond in writing within fifteen working days, detailing specific corrective steps, prevention plans, and a timetable for implementation, including documentation. The FDA emphasizes that this letter is not an exhaustive list of violations and the firm is responsible for overall compliance.