EYE-PAK OPHTHALMIC DRAPE

Additional Manufacturer Narrative

INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

Description of Event or Problem

A CUSTOMER REPORTED THAT A PATIENT EXPERIENCED A CORNEAL EPITHELIAL TEAR WHEN STICKING DOWN THE DRAPE. THE ISSUE CAUSED NO DELAY TO THE PROCEDURE, BUT POSTOPERATIVE DISCOMFORT AND PAIN. THE PATIENT WAS TREATED WITH A STEROID AND AN ANTIBIOTIC AND IS RECOVERING SLOWLY. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION.

Additional Manufacturer Narrative

THE LOT SPECIFIC TO THIS EVENT IS NOT KNOWN; THEREFORE, LOT HISTORY AND DEVICE HISTORY RECORD REVIEWS ARE NOT POSSIBLE. A SAMPLE HAS NOT BEEN RETURNED; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS NOT KNOWN; A SAMPLE WAS NOT RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE MOST LIKELY ROOT CAUSE OF THIS COMPLAINT IS AN ERROR THAT OCCURRED DURING THE SUPPLIER'S MANUFACTURING PROCESS. ANOTHER POTENTIAL ROOT CAUSE IS THE TECHNIQUE THAT IS USED TO REMOVE THE DRAPE. ACTION WILL NOT BE TAKEN FOR THIS OCCURRENCE AS THE ROOT CAUSE IS NOT KNOWN. QUALITY ASSURANCE WILL CONTINUE TO MONITOR AND TAKE ACTION FOR ANY FUTURE OCCURRENCES AS IS DEEMED NECESSARY. (B)(4).