FDA 483 - Alcon Research, LLC - December 05, 2019

During an inspection of Alcon Research, LLC in Irvine, CA, the FDA observed a significant issue regarding the labeling of their Class IV laser products. The firm failed to affix required DANGER logotypes and specific warning statements to their LenSx Laser Systems, which were distributed over an eight-year period. This lapse in labeling poses a potential safety risk to users of these medical devices.