ALCON CLOSURE SYSTEM (ACS), POLYESTER

Description of Event or Problem

A GOVERNMENT AGENCY REPORTED THAT AN OPHTHALMIC SURGICAL SUTURE NEEDLE WAS BROKEN DURING LEFT EYELID ECTROPION CORRECTION, FLAP REPAIR, AND INNER AND OUTER CANTHOPLASTY SURGERY. THE PATIENT UNDERWENT COMPUTED TOMOGRAPHY (CT) 7 FOR ORBITAL PLAIN SCAN AND THREE-DIMENSIONAL (3D) RECONSTRUCTION. IT WAS FOUND THAT THE BROKEN SUTURE NEEDLED WAS STILL IN THE PATIENT'S EYE. THE OTHER PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

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).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS PROVIDED IN SECTIONS H.6., AND H.11. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION FOR THE REPORT OF SUTURE NEEDLE BROKEN DURING USE; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE AND NO LOT INFORMATION WAS PROVIDED; THEREFORE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION OBTAINED; THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADVERSE TRENDS HAVE BEEN OBSERVED ASSOCIATED WITH THE REPORTED PRODUCT AND EVENT. NO FURTHER ACTIONS ARE REQUIRED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).