MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE V-LANCE KNIVES; KNIFE, OPHTHALMIC

Catalog Number	8065911901
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
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 customer reported that before surgery an ophthalmic knives from same lot number was found spiked and could not cut.There were several products from same lot which could not cut despite replacement.The surgery was performed and completed after replacing the products with another one.No patient harm was reported.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.Three opened and three unopened knives were received for the report of spiked, could not cut before surgery.Opened samples were visually inspected and were found nonconforming with bent tip and/or a damaged cutting edge.Penetration testing could not be performed due to the damage of the samples.Unopened samples were visually inspected and found to be conforming.Functional penetration testing was then performed, and all samples were found to be conforming.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 opened samples were visually non-conforming, with bent tip and/or a damaged cutting edge.The damage to the returned samples is consistent with damage that can occur when the blade contacts a hard surface such as the protective blade tray when product is improperly removed or inserted after use, or improper handling, or contact with another instrument during surgery or set-up.The returned unopened samples were visually and functionally conforming; therefore spiked, could not cut before surgery as described in the complaint were not confirm.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 for the opened samples and due to that the unopened samples met specification.All knives are 100% inspected by trained operators using a minimum of 10x magnification during manufacturing.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: V-LANCE KNIVES
• Common Device Name: KNIFE, OPHTHALMIC
• 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: 22313439
• Report Number: 2523835-2025-00694
• Device Sequence Number: 18346108
• Product Code: HNN
• UDI-Device Identifier: 00380659119019
• UDI-Public: (01)00380659119019(17)291031(11)241120(10)175FR0
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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 Catalogue Number: 8065911901
• Device Lot Number: 175FR0
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• 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