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	08/28/2026
Type of Reportable Event	Malfunction

• 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: 50910028
• Report Number: 2523835-2026-00977
• Device Sequence Number: 12281146
• Product Code: GAR
• UDI-Device Identifier: 00380651930018
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 09/27/2026

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: 17P5J9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/27/2026
• Date Device Manufactured: 10/02/2025
• 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