FDA 483 - LENSAR, Inc. - September 21, 2022

An FDA inspection of LENSAR, Inc. in Orlando, FL, a manufacturer of medical devices, identified one observation. The firm failed to submit a required Radiation Safety Product Report for its LENSAR ALLY™ Adaptive Cataract Treatment System before distributing the product into interstate commerce. This indicates a moderate administrative non-compliance related to product reporting requirements for laser systems.