MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS; DEVICE, IRRIGATION, OCULAR SURGERY

Catalog Number	8065751511
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2025
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 pharmacist reported that before cataract surgery an intrepid irrigation and aspiration tip of the centurion cassette pack was broken when opened.Patient impact was not reported.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.One opened angled (irrigation and aspiration) i/a tip was returned for the reported issue of a broken tip.The returned sample was visually inspected and was found to be non-conforming with the polymer i/a tip broken in two pieces at the cannula area that enters the over molded hub.No evidence of over torquing was observed, and the hub ribs were not twisted in a spiraling motion.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 returned non-conforming sample was received opened.How and when the i/a tip became damaged cannot be determined from this evaluation; therefore, a root cause cannot be determined for the complaint as described by the customer.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All i/a tips are 100% visually inspected prior to being released from the manufacturing facility.The manufacturer internal reference number is: (b)(4).

• Brand Name: DISPOSABLE POLYMER IRRIGATION AND SILICONE IRRIGATION AND ASPIRATION TIPS
• Common Device Name: DEVICE, IRRIGATION, OCULAR SURGERY
• 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: 21649832
• Report Number: 2523835-2025-00312
• Device Sequence Number: 7489475
• Product Code: KYG
• UDI-Device Identifier: 00380657515110
• UDI-Public: (01)00380657515110(17)260430(11)240502(10)16T0LF
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 8065751511
• Device Lot Number: 16T0LF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 06/15/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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