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

Catalog Number	8065304901
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/29/2026
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 government agency reported that an ophthalmic suture was used during phacoemulsification and aspiration combined with scleral-sutured intraocular lens implantation in the right eye.During the procedure, two sutures from the same batch ruptured under routine tension during tightening.The procedure was completed on the same day after switching to an alternative suture.The operation time was prolonged due to the suture ruptures.Patient impact has not been provided.Additional information has been requested but is not available at the time of this report.

• Brand Name: ALCON CLOSURE SYSTEM (ACS), PAIR PAK, POLYPROPYLENE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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: 25704617
• Report Number: 2523835-2026-00673
• Device Sequence Number: 9443479
• Product Code: GAW
• UDI-Device Identifier: 00380653049015
• UDI-Public: (01)00380653049015(17)300531(11)250625(10)17HH2E
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P890002
• 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): 07/03/2026

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: 8065304901
• Device Lot Number: 17HH2E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 07/03/2026
• Date Device Manufactured: 06/25/2025
• 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 Age: 68 YR
• Patient Sex: Male