FDA WARNING_LETTER - Nevyas Eye Associates - March 28, 2012

On June 5, 2012, the FDA issued a Warning Letter to Nevyas Eye Associates following a March 19-28, 2012 inspection in Bala Cynwyd, Pennsylvania. The firm, a medical device user facility, was found in violation of Medical Device Reporting (MDR) regulations (21 CFR Part 803). The ophthalmic laser used for LASIK procedures was deemed misbranded under Section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act due to failure to furnish required information under Section 519.

The significant violation identified was the firm's failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. The medical director and refractory consultants confirmed the absence of such procedures and their unawareness of reportable serious injuries, despite acknowledging that adverse events, including vision-threatening complications, had occurred.

The firm's April 2, 2012 response was deemed inadequate as it did not include a copy of the required MDR procedures. Nevyas Eye Associates must take prompt corrective action to avoid further regulatory actions, including seizure, injunction, civil money penalties, and potential impact on federal contracts. The firm must notify the FDA in writing within fifteen business days with specific steps taken to correct violations, prevent recurrence, and provide documentation or a timetable for completion.