NON-ABSORBABLE SURGICAL SUTURES

Additional Manufacturer Narrative

EVALUATION SUMMARY: ONE SUTURE LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER COMPLAINT WERE FOUND DURING THE LOT REVIEW. PRODUCT WAS RELEASED ACCORDING TO MANUFACTURER'S ACCEPTANCE CRITERIA. THE SUTURE LOT WAS DEEMED ACCEPTABLE WITH NO ABNORMALITIES. SUTURE TENSILE STRENGTHS AND DIAMETERS WERE DEEMED ACCEPTABLE. THE SUTURE SAMPLE WAS NOT RETURNED AND THE DEVICE HISTORY REVIEW OF THE LOT NUMBER INDICATED PRODUCT WAS RELEASED ACCORDING TO MANUFACTURER'S ACCEPTANCE CRITERIA. ALL SUTURE PRODUCTS ARE 100% VISUALLY INSPECTED, CHECKED FOR SECURE COMPONENT CONNECTIONS AND EACH SUTURE CARRIER IS VISUALLY INSPECTED FOR DIRT, A POOR DIE CUT, AND/OR LIGHT AND DARK SPOTS. ANY CARRIERS ON WHICH DEFECTS ARE FOUND ARE SCRAPPED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE FOR THE COMPLAINT ISSUE CANNOT BE DETERMINED SO NO MALFUNCTIONS WERE CONFIRMED. (B)(4).

Description of Event or Problem

A PHARMACIST ASSIST REPORTED THAT DURING CORNEAL SUTURE, A FRAGMENT OF THE POLYSTYRENE SUPPORT, ON WHICH THE STRING OF THE SUTURE KIT IS PLACED, ENTERED IN THE PATIENT'S CORNEA. THE PARTICLE WAS IMPOSSIBLE TO REMOVE DURING SURGERY BECAUSE THE FRAGMENT WAS TOO SMALL. THE PATIENT WILL HAVE A CLOSE MONITORING TO DETECT ANY INFLAMMATORY REACTION RELATED TO THE PRESENCE OF THIS INTRA CORNEAL FOREIGN BODY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE.