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

Catalog Number	8065193001
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that needles of ophthalmic sutures were not sharp.Procedure details and timing of the event are unknown, and there was no patient health impact.Additional information has been requested but is not available at the time of this report.
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).

• 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: 25814119
• Report Number: 2523835-2026-00737
• Device Sequence Number: 20324520
• Product Code: GAR
• UDI-Device Identifier: 00380651930018
• UDI-Public: (01)00380651930018(17)300630(11)250731(10)17KFRV
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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
• Report Date (Section B): 07/14/2026

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: 8065193001
• Device Lot Number: 17KFRV
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/14/2026
• Date Device Manufactured: 07/31/2025
• 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