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	No Clinical Signs, Symptoms or Conditions (4582)
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 during vitreoretinal surgery, the ophthalmic blade was found to be misshapen.It appeared tapered at the mid-shaft and did not fit into the trocar.Product details were not provided.The surgeon removed the blade and opened a new one, which fit as expected through the trocar.There was no impact on the patient, only a brief delay in exchanging the product during the procedure.
Additional Manufacturer Narrative
The initial decision to report was incorrect resulting in the initial report being submitted in error.This event (mishappen blade) is not considered to be a reportable malfunction, and it is not likely that a recurrence would result in serious injury.No further reports will be submitted under mfg report num: 2523835-2025-01297.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: 23788624
• Report Number: 2523835-2025-01297
• Device Sequence Number: 10453596
• Product Code: HNN
• UDI-Device Identifier: 00380659125010
• UDI-Public: (01)00380659125010(17)291231(11)250107(10)1772E7
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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