Staar Surgical Co. – FDA Warning Letter, Mar 21, 2014

The FDA issued a Warning Letter to Staar Surgical Company following an inspection from February 10 to March 21, 2014, which found their class III implantable lenses, including Visian ICL/MICL, to be adulterated. The firm's manufacturing, packing, storage, or installation methods and controls were not in conformity with the Quality System regulation (21 CFR Part 820). Key violations included widespread failures in design controls, such as lacking procedures for design controls, Design History Files (DHF), design transfer, design plans, design input documentation, design verification, design review, and design validation results. The firm also failed to validate device software, document design risk analysis, establish complaint handling procedures, revalidate processes, establish finished device acceptance procedures, ensure supplier qualification, and maintain required records. Staar Surgical's April 11, 2014 response was deemed inadequate, often lacking systemic corrective actions or complete documentation. The FDA requires prompt corrective action within fifteen business days, including documentation and a timetable, to prevent regulatory actions such as seizure, injunction, civil money penalties, and impacts on federal contracts or premarket approvals. The letter emphasizes the need for a comprehensive investigation into the root causes of these systemic quality management issues.