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

Catalog Number	8065912501
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/10/2025
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.A sample has been received by manufacturing that has not yet been evaluated.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during surgery, an ophthalmic knife was too thick and did not pass through the cannula.The surgery was completed on the same day.The patient impact have not been provided.Additional information has been requested, but none has been received to date.
Additional Manufacturer Narrative
Corrected information provided in sections b2 and h11.Upon further review, it was identified that the increased thickness was located in the middle portion of the knife within the shank area.There was no issue with the functional cutting tip of the knife.Based on this assessment, the thickness observed in the shank area is not considered a reportable malfunction, as no serious injury has occurred, and the condition is not likely to cause or contribute to a serious injury.Hence this complaint does not meet the criteria for regulatory reporting.No further reports will be submitted under mfg report num.2523835-2025-01283.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: 23755498
• Report Number: 2523835-2025-01283
• Device Sequence Number: 5904348
• 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
• Report Date (Section B): 01/30/2026

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?: Yes
• 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: 01/09/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/30/2026
• 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