Description of Event or Problem · 1
TTI RECEIVED REPORT OF AN PATIENT ADVERSE EVENT FROM SALES REP, (B)(6). THE INITIAL COMMUNICATION STATED THAT THE PATIENT WAS TREATED WITH PROKERA SLIM FOR RECURRENT CORNEAL EROSION. TTI MEDICAL DIRECTOR WAS NOTIFIED OF THIS EVENT ON (B)(6) 2021. THE TREATING PHYSICIAN PERFORMED A DEBRIDEMENT AND PLACED A PKS ON THE EYE, AND PRESCRIBED THE PATIENT OFLOXICIN. THE PATIENT EXPERIENCED CONTINUOUS EYE TEARING AND THE FORMATION OF CYSTS ON THE EYE. THE PATIENT WAS THEN REFERRED TO A CORNEA SPECIALIST WHO SCRAPED THE EYE AND PLACED A BANDAGE CONTACT LENS. THE INITIAL COMMUNICATION STATED THAT THE PATIENT IS WELL AND THE PATIENT SYMPTOMS RESOLVED AFTER PLACEMENT OF THE BANDAGE CONTACT LENS. THE TREATING PHYSICIAN WAS CONTACTED TO PROVIDE ADDITIONAL INFORMATION BUT A RESPONSE HAS NOT YET BEEN RECEIVED. NO PRODUCT DEFECT WAS REPORTED BY THE CUSTOMER. THE FORM INDICATED THE DEVICE WAS DISCARDED BY THE CUSTOMER. THE MANUFACTURING BATCH RECORD FOR ASSOCIATED LOT WAS REVIEWED AND NO NONCONFORMITIES IDENTIFIED. REVIEW OF COMPLAINT RECORDS INDICATE NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THE ASSOCIATED LOT.