FDA 483 - Johnson & Johnson Surgical Vision Inc - June 25, 2007

The FDA Form 483 details multiple violations observed during an inspection. The facility failed to submit Medical Device Reports (MDRs) within 30 days for numerous complaints referencing Acanthamoeba keratitis and Serratia marcescens eye infections, despite being aware of these serious injuries. Specific complaints (e.g., #61130, #68736, #66614) were not reported according to the established timeline.

Additionally, investigations for several complaints were incomplete. For Acanthamoeba keratitis cases, microbial evaluations identified protozoans but did not specify the type, and retained samples were not tested using the same method as complaint units. For Serratia marcescens cases, the amount of bacteria was not quantified, and the bacterium was not isolated and tested against retained units to confirm lot efficacy. Some investigations also failed to determine the type or material composition of contact lenses worn by complainants.

The firm did not follow its Corrective and Preventive Action (CAPA) procedures (QSOP002, Rev. 09), as an Action Request was not created for the voluntary recall of Complete MoisturePlus contact lens solutions or for the decision to readdress MDR reportability for corneal ulcers, eye infections, and keratitis.

Design control deficiencies were noted: Design verification for the Antimicrobial Efficacy-Regimen Test (4 Hour Soak) was performed under "best case conditions" using product lots with preservative levels at the