MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE ALCON CLOSURE SYSTEM (ACS), NYLON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Catalog Number	8065202001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A physician reported that before the surgery the ophthalmic suture was shredded and also foreign materials found.Procedure details and patient impact were not reported.
Additional Manufacturer Narrative
One opened suture, in a blister and in a pouch, in a bag was received for the report of shredded thread and white foreign material.The returned sample was visually inspected and found to be nonconforming, the suture was broken.No foreign material observed on the suture.A dimensional inspection for suture diameter and a functional test for suture tensile strength was performed and the sample was found to be conforming for both tests.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The returned sample was found to be non-conforming visually with a broken suture, however the sample was conforming for all functional and dimensional testing associated with the reported event, therefore shredded thread as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.The returned sample was found to visually conforming, therefore white foreign material as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the suture was manufactured to specifications.Suture material samples are tested at incoming for tensile strength and diameter and visually inspected for any defects such as discoloration and frays.Sutures are also 100% inspected by trained operators for discoloration and frays and for proper attachment during the manufacturing process.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).

• Brand Name: ALCON CLOSURE SYSTEM (ACS), NYLON
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18356075
• Report Number: 2523835-2023-00731
• Device Sequence Number: 12484097
• Product Code: GAR
• UDI-Device Identifier: 00380652020015
• UDI-Public: 00380652020015
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K930517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065202001
• Device Lot Number: 1529KD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 03/31/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown