MAUDE Adverse Event Report: Alcon Research, LLC - Alcon Precision Device Alcon Closure System (ACS), Nylon; Suture, Nonabsorbable, Synthetic, Polyamide

Catalog Number	8065698001
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that, during surgery white ophthalmic suture was found inside the pack instead of black suture when the package was opened.The surgery was completed on the same day without any patient harm.
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).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 ; +1(800)757-9780
• MDR Report Key: 50898730
• Report Number: 2523835-2026-00972
• Device Sequence Number: 5829461
• Product Code: GAR
• UDI-Device Identifier: 00380656980018
• UDI-Public: (01)00380656980018(17)290228(11)240321(10)16N2JE
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 09/25/2026

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: 8065698001
• Device Lot Number: 16N2JE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 03/21/2024
• 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