MAUDE Adverse Event Report: ALCON GRIESHABER AG GRIESHABER REVOLUTION DSP FORCEPS; FORCEPS, OPHTHALMIC

Catalog Number	705.44
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument was received in its inner and outer blister, covered with the tyvek lid foil showing the lot information.However, the instrument was not positioned correctly in the inner blister.The device shows macroscopic signs of damage, namely, the forceps arms are slightly bent and the forceps is not fully open.There are signs of surgical residues.The instrument was visually inspected with the aid of a photomicroscope using various magnifications and was functionally tested.It was found during the inspection that the actuation mechanism works as intended.When actuating the mechanism, the forceps opened and closed without an increased amount of friction or any blocking.The opening of the grasping arms was then tested with the relevant inspection equipment and it was found that the opening of the forceps is too small.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 placed on the device be reconstructed.The customer¿s complaint is confirmed, but a root cause for the failure cannot be determined conclusively.A review of the batch 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.Since the situation that lead to the issue can not be reconstructed, a root cause for the customer's reported event could not be determined conclusively.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.Complaint data for all manufacturer products is reviewed monthly to monitor for adverse trends.During the last review, no adverse trends were observed for the reported product and event combination.The complaint data will continue to be monitored for evidence of adverse trending and further action will be taken, as appropriate.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported that an ophthalmic forceps did not open.Patient details were unknown.Procedure was completed with other forceps.Additional information has been requested but is not available at the time of this report.

• Brand Name: GRIESHABER REVOLUTION DSP FORCEPS
• Common Device Name: FORCEPS, 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: 25409791
• Report Number: 3003398873-2026-00110
• Device Sequence Number: 21414297
• Product Code: HNR
• UDI-Device Identifier: 07612717064263
• UDI-Public: (01)07612717064263(17)280930(11)251030(10)17RRUH
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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: 705.44
• Device Lot Number: 17RRUH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2025
• 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 Age: 74 YR
• Patient Sex: Male