ALCON CLOSURE SYSTEM (ACS), POLYESTER

Additional Manufacturer Narrative

A SAMPLE WAS NOT RECEIVED AT INVESTIGATION SITE FOR EVALUATION FOR THE REPORT OF WOUND LEAKAGE, SUTURE BREAKAGE AFTER THREE WEEKS OF SURGERY; 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 INVESTIGATION SITE AND NO LOT INFORMATION IS AVAILABLE, 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 ADDITIONAL ACTION IS REQUIRED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

Description of Event or Problem

A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW-UP STUDY INDICATED THAT THE PATIENT UNDERWENT A SURGERY IN THE EYE (UNKNOWN) USING THREE DIFFERENT OPHTHALMIC SUTURES. THE SURGERY WAS COMPLETED ON THE SAME DAY. THREE WEEKS POST-SURGERY THE SUTURE BREAKAGE HAD OCCURRED AND THE PATIENT EXPERIENCED WOUND LEAKAGE FOR WHICH TREATMENT WAS PROVIDED AS AN INTERVENTION. THE TYPE OF PROCEDURE HAS NOT BEEN PROVIDED. THE CURRENT CONDITION OF THE PATIENT WAS UNKNOWN. NO FURTHER FOLLOW UP WILL BE CONDUCTED.

Description of Event or Problem

A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW-UP STUDY INDICATED THAT THE PATIENT UNDERWENT A SURGERY IN THE EYE (UNKNOWN) USING FOUR DIFFERENT OPHTHALMIC SUTURES.

Additional Manufacturer Narrative

CORRECTION INFORMATION WAS PROVIDED IN SECTIONS B5. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.