PROKERA SLIM

Description of Event or Problem

A TREATING PHYSICIAN RELAYED A RECENT EVENT VIA LOCAL REPRESENTATIVE IN WHICH A FEW DAYS AFTER PROKERA SLIM DEVICE PLACEMENT, THE PATIENT RETURNED WITH SWOLLEN EYELIDS, OCULAR REDNESS, THICK DISCHARGE AND PAPILLAE. THE PHYSICIAN INITIALLY STATED THE EYE LOOKED LIKE A BACTERIAL INFECTION ALTHOUGH NO CULTURE WAS PERFORMED TO CONFIRM. A PROKERA SLIM HAD BEEN PLACED ON THE RIGHT EYE ON AN UNDISCLOSED DATE (PRIOR TO ON (B)(6) 2026) FOR MANAGEMENT OF NEUROTROPHIC KERATITIS. THERE WERE NO COMPLICATIONS OR DISCOMFORT DURING DEVICE PLACEMENT, HOWEVER, IT WAS NOTED THAT THE PATIENT HAD TIGHT EYELIDS. THE PATIENT WORE THE DEVICE FOR APPROXIMATELY TWO DAYS AND RETURNED FOR SCHEDULED REMOVAL WITH SWOLLEN, IRRITATED EYELIDS. CLINICAL EXAM NOTED OCULAR REDNESS, THICK DISCHARGE AND PAPILLAE "ALL AROUND". SYMPTOMS RESOLVED A FEW DAYS AFTER DEVICE REMOVAL. A SECOND SIMILIAR EVENT OCCURRED WITH THIS PATIENT LATER IN THE LEFT EYE WITH A PROKERA EARLIER, AND THE PATIENT HAD THE SAME SYMPTOMS, WHICH WERE TREATED WITH ANTIBIOTIC DROPS. IT IS UNCLEAR IF THE INITIAL CASE WAS ALSO TREATED WITH ANTIBIOTIC DROPS, BUT AS THE EVENTS ARE SO SIMILAR AND THE PATIENT WAS SEEN BY THE SAME PHYSICIAN, THIS IS BEING PRESUMED. NO PRODUCT DEFECTS OR MALFUNCTION WERE REPORTED.

Additional Manufacturer Narrative

THE MANUFACTURER INTERNAL REFERENCE NUMBER FOR THIS EVENT IS (B)(4). THE PKS DEVICE WAS NOT RETURNED TO BIOTISSUE FOR FURTHER EVALUATION. THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED ALTHOUGH NO DEFECTS OR MALFUNCTIONS WERE REPORTED AS PART OF THE COMPLAINT. THE LOT INFORMATION WAS ALSO UNKNOWN AS THIS INFORMATION WAS NOT REPORTED. RECEIPT OF ADDITIONAL RELEVANT INFORMATION OR SUPPORTING MATERIALS WILL PROMPT A RE-EVALUATION OF THE EVENT. NO FURTHER ACTION WARRANTED AT THIS TIME. THIS IS THE FIRST OF TWO ADVERSE EVENTS REPORTED FOR THIS PATIENT. A SECOND PROKERA SLIM DEVICE WAS USED IN THE PATIENT'S FELLOW EYE WITH SIMILAR SIGNS AND SYMPTOMS RESULTING, SUGGESTING THIS MAY BE A PATIENT FIT ISSUE (PATIENT NOTED TO HAVE TIGHT EYELIDS).