PROKERA SLIM

Description of Event or Problem

A PHYSICIAN REPORTED A CASE INVOLVING A PATIENT TREATED WITH PROKERA SLIM ON (B)(6) 2026 TO TREAT A DEEP CENTRAL RECURRENT CORNEAL EROSION (RCE) WHICH DEVELOPED CORNEAL INFILTRATES PRESUMED TO BE INFECTIOUS. ON (B)(6) 2026, THE PATIENT RETURNED FOR DEVICE REMOVAL AND REPORTED PAIN, STINGING, AND TEARING. AFTER REMOVAL, MULTIPLE CORNEAL INFILTRATES WERE OBSERVED, PRESUMED TO BE INFECTION BY THE TREATING PHYSICIAN. NO CULTURES WERE TAKEN TO CONFIRM. THE ALREADY IN USE PROPHYLACTIC ANTIBIOTIC DROP FREQUENCY WAS INCREASED FROM TID TO Q1H. ON (B)(6) 2026, SYMPTOMS HAD NOT IMPROVED, AND THE CORNEAL DEFECT WORSENED. A SECOND ANTIBIOTIC WAS ADDED, ALTERNATING HOURLY WITH POLYTRIM, AND A NIGHTTIME LUBRICATING OINTMENT WAS STARTED. ON (B)(6) 2026, THE EYE BEGAN TO IMPROVE. A STEROID EYE DROP WAS STARTED QID, AND ANTIBIOTIC USE WAS REDUCED TO Q2H. BY ON (B)(6) 2026, THE INFECTION HAD RESOLVED, AND THE CORNEA WAS HEALING. THE STEROID WAS INCREASED IN FREQUENCY, AND ANTIBIOTICS WERE REDUCED TO FOUR TIMES DAILY. CONTINUED IMPROVEMENT WAS SEEN ON (B)(6) 2026, AND TREATMENT WAS CONTINUED. BY ON (B)(6) 2026, THE PATIENT'S SYMPTOMS HAD RESOLVED AND THE EYE HAD HEALED. ANTIBIOTICS WERE STOPPED AND THE STEROID WAS FURTHER REDUCED TO TAPER. THE EVENT WAS CONSIDERED RESOLVED. NO DEFECTS OR MALFUNCTIONS WERE REPORTED RELATED TO THE PROKERA SLIM DEVICE.

Additional Manufacturer Narrative

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. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER, INDICATES THAT THE REPORTED PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE REPORTED PRODUCT'S ACCEPTANCE CRITERIA. THE INVESTIGATION CONDUCTED A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER. NO DEVIATIONS WERE IDENTIFIED AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. BASED ON THE EVALUATION OF THE INFORMATION RECEIVED, THE INVESTIGATION WAS UNABLE TO IDENTIFY THE ROOT CAUSE OR ORIGIN OF THE REPORTED EVENT. ADDITIONALLY, NO MANUFACTURING-RELATED DEFICIENCIES WERE FOUND THAT POTENTIALLY WOULD HAVE CONTRIBUTED TO THE COMPLAINT. AS THE ROOT CAUSE AND ITS ORIGIN ARE INCONCLUSIVE, FURTHER INVESTIGATIVE OR MANUFACTURING ACTIONS ARE NOT WARRANTED AT THIS TIME. RECEIPT OF ADDITIONAL RELEVANT INFORMATION OR SUPPORTING MATERIALS WILL PROMPT A RE-EVALUATION OF THE EVENT. NO FURTHER ACTION WARRANTED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER FOR THIS EVENT IS (B)(4).