FDA 483 - EyeKon Medical, Inc. - June 10, 2025

An FDA inspection of EyeKon Medical, Inc. in Clearwater, FL, revealed significant deficiencies in their quality management system. The firm failed to adequately implement corrective and preventive actions, properly handle customer complaints, maintain calibrated equipment, and define controls over consultants. These issues indicate a systemic breakdown in ensuring product quality and regulatory compliance for their Hydrophilic Acrylic Intraocular Lenses.