Intraocular Lensmaker Cited for CAPA, Documentation Issues

EyeKon Medical failed to monitor its water system for polishing, hydrating and filling vials used with its hydrophilic acrylic intraocular lenses, according to an FDA warning letter. When the employee designated to test water samples for microbial and pyrogenic quality was unavailable, EyeKon failed to assign a substitute worker to perform the testing. An FDA inspection of the company’s Florida plant last fall also showed that EyeKon failed to completely implement and document results of multiple corrective and preventive actions (CAPAs).
Devices & Diagnostics Letter