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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A PATIENT REPORTED SHE EXPERIENCED REDNESS AND PEELING OF THE SKIN AROUND THE CHEEK AND TEMPLE AREA AFTER UNDERGOING A CATARACT EXTRACTION ON HER RIGHT EYE. THE PATIENT INITIALLY INDICATED SHE USED CORTISONE CREAM AND THE ISSUE RESOLVED AFTER TEN DAYS. ADDITIONAL INFORMATION FROM THE PATIENT WAS RECEIVED. THE PATIENT INDICATED THE SKIN WAS REMOVED WITH THE DRAPE FROM THE CHEEK AND TEMPLE AREA. SHE APPLIED A TRIPLE ANTIBIOTIC OINTMENT FOR WEEKS AND THE AREA HEALED WITH NO SCARRING OR RESIDUAL EFFECTS. NO ADDITIONAL INFORMATION IS EXPECTED. THIS IS ONE REPORT OF TWO FOR THIS PATIENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED IN H.6. AND H.10. THE CUSTOMER DID NOT RETAIN THE PRODUCT LOT INFORMATION FOR THIS CUSTOM PAK PROCEDURE PACK, THEREFORE THE DEVICE HISTORY RECORDS TRACEABLE TO THE REPORTED PACK COULD NOT BE REVIEWED. THE CUSTOMER REPORTED "THIS IS NOT A COMPLAINT AGAINST ALCON." IT WAS REPORTED A DRAPE REMOVED SKIN FROM THE PATIENT'S CHEEK. THE DRAPE REPORTED ORIGINATES FROM A SUPPLIER MANUFACTURER. NO SAMPLE HAS BEEN RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED TO SUGGEST THE ROOT CAUSE ORIGINATED FROM THE DRAPE OR OPERATOR ERROR. WHEN THIS TYPE OF ISSUE OCCURS, A SAMPLE(OR IMAGE) SHOULD BE RETURNED SO THAT A ROOT CAUSE EVALUATION CAN BE PERFORMED. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE ESTABLISHED AS A SAMPLE HAS NOT BEEN RECEIVED AND THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. WITHOUT ANALYSIS OF THE SAMPLE, IT IS NOT POSSIBLE TO ISOLATE THE ROOT CAUSE. AS THE ROOT CAUSE IS UNKNOWN, THE RELATIONSHIP, IF ANY, OF THE DEVICE TO THE REPORTED INCIDENT CANNOT BE DETERMINED. AFTER AN INVESTIGATION OF THIS COMPLAINT, IT HAS BEEN DETERMINED THAT NO ACTION WILL BE TAKEN AT THIS TIME AS A SAMPLE WAS NOT RETURNED AND A ROOT CAUSE EVALUATION COULD NOT BE PERFORMED. ALL LOTS ARE VERIFIED THAT ALL REQUIRED INSPECTIONS HAVE BEEN PERFORMED AND ALL ACCEPTANCE CRITERIA ARE MET PRIOR TO RELEASE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).