FDA 483 - Lights' Prosthetic Eyes Inc - September 19, 2025

Lights' Prosthetic Eyes Inc. in Peoria, IL, a manufacturer of Class 2 Scleral Shells, received a Form FDA 483 with four observations highlighting significant deficiencies in its quality system. The firm failed to establish adequate procedures for corrective and preventive actions, medical device reporting, quality audits, and management review, with several issues being repeat observations. These findings indicate a fundamental lack of critical quality system controls.