MAUDE Adverse Event Report: ALCON GRIESHABER AG REVOLUTION HANDLE; SCISSORS, OPHTHALMIC

Catalog Number	712.00.42
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
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 vitrectomy surgery, an ophthalmic revolution handle had installed new forceps tips multiple times on the handle, but none of them could be installed.The procedure was completed on the same day by installing the new forceps tip and was used normally on the same and old handle model.No patient harm was reported.
Additional Manufacturer Narrative
Additional information provided in sections d.9., h.3., h.6., and h.11.The investigation is completed based on the sample evaluation outlined below.The returned instrument was received in a sterilization foil bag.The original packaging was missing.The product shows macroscopic signs of damage, namely that the front part is severely scratched and has sharp burrs marks on the edges.It was not possible to assemble a tip.As the blister was opened by the customer, the product was handled.Therefore, the point in time when the malfunction occurred can no longer be determined, nor can the strain put on the device be reconstructed.The customer¿s complaint is confirmed, but a root cause for the failure cannot be determined.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.Non-conformance report provided by originator.A non-conformance-based review of the lot number was performed and did not reveal any potential contributing factors to the reported complaint.No root cause for the customer's reported event could be determined, since the situation that lead to the handle failure cannot be reconstructed.As the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.The manufacturer internal reference number is: (b)(4).

• Brand Name: REVOLUTION HANDLE
• Common Device Name: SCISSORS, 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: 22024052
• Report Number: 3003398873-2025-00284
• Device Sequence Number: 18420699
• Product Code: HNF
• UDI-Device Identifier: 07612717058439
• UDI-Public: (01)07612717058439(17)331231(11)240119(10)16FFC2
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: 712.00.42
• Device Lot Number: 16FFC2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown