FDA EIR - SurgiLight, Inc. - January 05, 2004

An FDA inspection of SurgiLight, Inc., conducted from December 2003 to January 2004, focused on their OptiVision laser for laser presbyopia reversal (IDE: G010271). The inspection, performed under CP:7348.810 and guided by sponsor responsibilities under regulations like 21 CFR 812.140(b), revealed several significant compliance issues documented on an FDA Form 483. Main violations included the sponsor's failure to ensure investigators complied with the study protocol, specifically regarding surgical incision depth limits and prohibiting same-day bilateral eye treatments. Investigators also failed to obtain informed consent prior to conducting pre-operative screenings and examinations. Inaccurate monitoring reports falsely claimed protocol adherence at sites with known deviations. Furthermore, device accountability records were incomplete, lacking serial numbers for lasers and fiberoptic components, and shipment/return data. Critically, SurgiLight failed to timely report an unanticipated adverse device effect involving a malfunctioning laser used on a subject with non-protocol settings before repair. SurgiLight's CEO, Dr. Colette Cozean, indicated she would provide a written response to the FDA addressing all observations, which will then be reviewed by the agency.