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

Catalog Number	8065192101
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008); Unexpected Color (4055)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample has been received by manufacturing that has not yet been evaluated.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 nurse reported that the ophthalmic sutures from two different lots were unusual in color, thinner than normal, and broke easily prior to surgery.Procedure details were not reported.Additional information has bee requested but none received till date.
Additional Manufacturer Narrative
Additional information was provided in sections d.9,h.3,h.4, h.6.And h.11.One opened sutures, in a pouch, in a blister, in a bag was received for the report of they have a different color than usual, lighter, thinner and easily broken.Sample was visually inspected and found to be nonconforming, suture is light in color, not black.A dimensional inspection was done for suture diameter and sample was found to be conforming.Functional testing for suture strength was performed and sample was found to be conforming.Functional channel smash was performed and both sample 1 and 2 were found to be conforming with black suture.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 samples were found to be non-conforming visually, however the samples were conforming for all functional and dimensional testing associated with the reported event, therefore suture thinner and easily broken as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.The suture was found light in color; however since the suture color within the channel was confirmed as black; a root cause cannot be determined for the complaint as described by the customer.The exact root cause for the discoloration cannot be confirmed as suture color within the channel was black and the sutures met specifications for dimensional and functional testing.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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 19423023
• Report Number: 2523835-2024-01160
• Device Sequence Number: 12846158
• Product Code: GAR
• UDI-Device Identifier: 00380651921016
• UDI-Public: (01)00380651921016(17)270531(11)220621(10)14UTEV
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K930517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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: 8065192101
• Device Lot Number: 14UTEV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 11/09/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• 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