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	8065751510
Medical Device Problem Codes	Obstruction of Flow (2423); Sharp Edges (4013)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that during cataract surgery with disposable irrigation and aspiration tip (i/a tip) customer felt stuck at the time of irrigation and aspiration.Customer thought there was burr in the tip of the polymer ia (port part).The patient experienced capsule rupture.Anterior vitrectomy surgery was performed, and the surgery was completed.The current condition of the patient was unknown.
Additional Manufacturer Narrative
The sample has been received and in-house evaluation is in progress.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).
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.One opened irrigation and aspiration (i/a) tip in a tip wrench in a zip top bag was received for the report that the i/a tip felt stuck during irrigation and aspiration and a burr at the tip was observed resulting in a capsule rupture.The sample was visually inspected and found to be conforming.No burr or any visual nonconformance was observed.The sample was then functionally tested for occlusion and was deemed conforming with good water flow observed exiting the i/a tip and no foreign material was observed on the filtered paper.A review of the device history record traceable to the reported lot, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The investigation conducted a non-conformance review of the reported lot.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Based on the evaluation of the information and materials received, the investigation concluded that the root cause of the reported event is not determined as the returned sample was conforming for all visual and functional testing for the reported occlusion and burr.No further investigative or manufacturing actions are warranted at this time due to that the returned sample met specifications for the reported occlusion and burr.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.Complaint data for all manufacturer products is reviewed monthly to monitor for adverse trends.During the last review, no adverse trends were observed for the reported product and event combination.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action warranted at this time.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: 23554308
• Report Number: 2523835-2025-01196
• Device Sequence Number: 10132319
• Product Code: KYG
• UDI-Device Identifier: 00380657515103
• UDI-Public: (01)00380657515103(17)270131(11)250220(10)1794D7
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065751510
• Device Lot Number: 1794D7
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown