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

Catalog Number	8065912501
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Dull, Blunt (2407)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/12/2025
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 physician reported that during surgery, the middle part of ophthalmic knife was thick and did not pass through cannula.The surgery was completed on the same day.Procedure details and patient impact were not reported.Additional information requested and none received till date.
Event or Problem Description
Additional information received indicated that the issue was related to a thick shank in the ophthalmic knife.
Additional Manufacturer Narrative
Additional information is provided in sections b.5 and h.6.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Corrected information was provided in sections b.2 and h.11.The initial decision to report was incorrect resulting in the initial report being submitted in error.This event middle part of knife was thick and did not pass through cannula is not considered to be a reportable malfunction, and it is not likely that a recurrence would result in serious injury.The fda product code a010103 has been retracted.No further reports will be scheduled under mfg report num: 2523835-2025-01293.The manufacturer internal reference number is:(b)(4).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: 23777133
• Report Number: 2523835-2025-01293
• Device Sequence Number: 13281703
• Product Code: HNN
• UDI-Device Identifier: 00380659125010
• UDI-Public: (01)00380659125010(17)291231(11)250107(10)1772E7
• 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,Followup
• Report Date (Section B): 02/05/2026

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: 8065912501
• Device Lot Number: 1772E7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 01/09/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/05/2026; 02/05/2026
• Date Device Manufactured: 01/07/2025
• 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 Sex: Unknown