MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER ULTRASHARP KNIFE; KNIFE, OPHTHALMIC

Catalog Number	681.05
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
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 during right eye cataract surgery ophthalmic knife was not cutting.Surgery was completed on the same day there was no patient harm.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.The returned instrument was received in its inner and outer blister covered with the tyvek lid foil, showing the lot information.The device shows no macroscopic signs of damage.There are signs of surgery residues.The returned instrument was visually inspected with the aid of a photomicroscope using various magnifications.During the visual inspection, no abnormalities could be identified.The blade showed no bending, no burrs or rough edges were present on the returned instrument.The instrument was then functionally tested and appeared to be working normally.Therefore, the customer¿s complaint could not be confirmed.A review of the device history record traceable to the reported lot numbers, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.A non-conformance based review of the lot number was performed and did not reveal any potential contributing factors to the reported complaint.A root cause for the customers reported event could not be determined because the returned product met manufacturer¿s specifications.No action was taken as the returned instrument met specifications for tests performed in relation to the reported event.The manufacturer internal reference number is: (b)(4).

• Brand Name: GRIESHABER ULTRASHARP KNIFE
• Common Device Name: KNIFE, OPHTHALMIC
• Manufacturer (Section D): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer (Section G): ALCON GRIESHABER AG; winkelriedstrasse 52; schaffhausen 8203 ; SZ 8203
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23987589
• Report Number: 3003398873-2026-00007
• Device Sequence Number: 4630268
• Product Code: HNN
• UDI-Device Identifier: 07612717000063
• UDI-Public: (01)07612717000063(17)280630(11)230703(10)15VW0Y
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 681.05
• Device Lot Number: 15VW0Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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