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

Catalog Number	8065195601
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
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 cataract surgery in an ophthalmic suture, needle at the tip was found broke off when opened.The surgery was performed and completed after replacing the product with another one.There was no patient harm.
Additional Manufacturer Narrative
One opened ophthalmic suture, in sheathing, within a blister was received in a bag for the reported issue of the needle tip was found broke off.The returned sample was visually inspected and was found to be nonconforming with the tip of the needle broke off.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 investigation conducted a non-conformance review of the reported [lot/batch/serial] number.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Based on the evaluation of the information and materials received, the investigation was unable to identify the root cause or origin of the reported event.The evaluation of the returned sample confirmed the reported issue of the needle tip was found broke off.How and when the tip of the needle broke off could not be determined.The most likely root cause is handling of the device; however, a manufacturing related handling root cause could not be ruled out.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.A nonconformance record was completed to determine the root cause for a broken tip.All suture needles are 100% inspected by trained operators using a minimum of 10x magnification during manufacturing.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.Complaint data for all manufacturer products is reviewed monthly to monitor for adverse trends.During the last review, no adverse trends were observed for the reported product and event combination.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ALCON CLOSURE SYSTEM (ACS), SILK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• 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: 22318444
• Report Number: 2523835-2025-00697
• Device Sequence Number: 15661042
• Product Code: GAP
• UDI-Device Identifier: 00380651846012
• UDI-Public: (01)00380651846012(17)290731(11)240822(10)1714D9
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K760158
• 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): 10/30/2025

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: 8065195601
• Device Lot Number: 1714D9
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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