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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
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 nurse reported that an ophthalmic tip was found to be bent before cataract surgery.Surgery was completed after replacing a product with new one.No patient impact was reported.
Additional Manufacturer Narrative
Additional information was provided in sections h.6 and h.11.No technical inquiries were received from the customer.One opened ophthalmic tip sample was received for the report a bent tip.The returned sample was visually inspected and found to be non-conforming, the i/a tip was observed to be bent.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 investigation conducted a non-conformance review of the reported lot number.No deviations were identified and all corresponding production release specifications defined in the device master record were met.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.Most likely root cause is handling when placing the tip onto the handpiece.Based on the evaluation of the information received, the investigation was unable to identify the root cause or origin of the reported event.Additionally, no manufacturing-related deficiencies were found that potentially could have contributed to the complaint.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.All i/a tips are 100% visually inspected prior to being released from the manufacturing facility.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: 22518769
• Report Number: 2523835-2025-00779
• Device Sequence Number: 15685352
• Product Code: KYG
• UDI-Device Identifier: 00380657515110
• UDI-Public: (01)00380657515110(17)260531(11)240611(10)16VTM7
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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: 05/31/2026
• Device Catalogue Number: 8065751511
• Device Lot Number: 16VTM7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CUSTOM-PAK SURGICAL PROCEDURE PACK
• Patient Sex: Unknown