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

Catalog Number	681.05
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
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 nurse reported that during vitreoretinal surgery, an ophthalmic tip broke off.The broken tip was recovered from the suction canister.The surgery was completed by using the new device.There was no patient impact was reported.
Additional Manufacturer Narrative
A manufacturing device history record (dhr) review was performed to ensure that the product was manufactured in compliance with the device master record.A review of the database for the non-conformance events and the complaints showed that the given lot number was not concerned by any relevant deviation and that there are no additional complaints associated with it.The concerned sample was not received at the investigation site for evaluation.Therefore, no further assessment is possible and the investigation is concluded without identifying the root cause.A sample was not received at the investigation site and not enough information was provided for further investigation.Therefore, the root cause for the customer complaint issue cannot be determined conclusively.The exact root cause for the customer's reported event is unknown, therefore, specific action cannot be taken.Complaints are reviewed and monitored at regular intervals for adverse trends.No adverse trends have been observed associated with the reported product and event.No action has been identified for this reported event.If new information is received, this case will be re-opened and the input will be considered and reflected.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: 21469844
• Report Number: 3003398873-2025-00200
• Device Sequence Number: 8658939
• Product Code: HNN
• UDI-Device Identifier: 07612717000063
• UDI-Public: (01)07612717000063(17)290430(11)240527(10)16UPU7
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 681.05
• Device Lot Number: 16UPU7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 05/13/2025
• Date Device Manufactured: 05/27/2024
• 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