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

Catalog Number	8065198001
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample has been available that has not yet reached manufacturing for evaluation.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
The customer reported that ophthalmic suture needles was found to blunt.Details of the procedure and any patient impact have not yet been provided.Additional information has been requested.
Additional Manufacturer Narrative
Additional information is provided in sections b3, b5, and h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information indicated that the event occurred during a trabeculectomy surgery in the right eye.The surgery was completed on the same day using an alternative suture, and there was no patient harm.
Additional Manufacturer Narrative
Corrected information is provided in sections h.6 (fda component code).Additional information is provided in sections h.6 and h.11.A sample was not received at the manufacturing site for evaluation for the report of needles appear to be blunt; therefore, the condition of the product could not be verified.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 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.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.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 manufacture 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).
Event or Problem Description
The customer reported that ophthalmic suture needles was found to blunt.Details of the procedure and any patient impact have not yet been provided.Additional information has been requested.Additional information indicated that during right eye trabeculectomy surgery ophthalmic suture needles was found to blunt.The surgery was completed on the same day by using alternative suture.There was no patient harm.

• 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: 24114350
• Report Number: 2523835-2026-00090
• Device Sequence Number: 15877374
• Product Code: GAR
• UDI-Device Identifier: 00380651980013
• UDI-Public: (01)00380651980013(17)300430(11)250529(10)17F476
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K930517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/24/2026

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: 8065198001
• Device Lot Number: 17F476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 01/23/2026; 04/13/2026; 06/05/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 01/30/2026; 04/17/2026; 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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