FDA 483 - Midwest Eye Laboratories Inc - December 13, 2023

Midwest Eye Laboratories Inc, a medical device manufacturer in Rochester, MN, was cited for significant deficiencies during an FDA inspection. The firm failed to properly label its Artificial Eye, Scleral Shell, and Ocular Conformer devices with Unique Device Identifiers (UDI) and did not submit required device information to the Global Unique Device Identification Database (GUDID). Additionally, the company's quality system procedures lacked proper documentation of approval dates and signatures.