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

Catalog Number	705.13P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during a combined cataract and vitrectomy surgery, the ophthalmic tip of the product could not be opened.The procedure was completed successfully after replacing the product with an alternative.No patient harm was reported.
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).
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.The returned instrument was received at the investigation site in its outer blister, covered with the tyvek lid foil which shows the lot information.The inner blister which offers protection during the shipment was not used.The instrument evidently shows macroscopic sign of damage.Specifically, the tube is significant bent.The device was returned in a closed state.The returned instrument was visually inspected with the aid of a photomicroscope using various magnifications.The visual inspection confirmed the the deformation of the forceps arms as well.The level of damage as well as the missing inner blister suggest that the deformation of the forceps arms and the tube was caused during the shipping process from the complainant to the investigation site.As the blister was opened by the customer, the product was handled.Therefore, the point in time when the defect occurred can no longer be determined, nor can the strain put on the device be reconstructed.The customer's complaint is therefore confirmed but the root cause cannot be identified by this investigation.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 it cannot be determined how or where the damage to the sample occurred.Therefore, the root cause for the customer's reported event could not be determined.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).

• Brand Name: GRIESHABER MAXGRIP 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: 23450464
• Report Number: 3003398873-2025-00399
• Device Sequence Number: 9174432
• Product Code: HNR
• UDI-Device Identifier: 07612717070721
• UDI-Public: (01)07612717070721(17)270930(11)241025(10)1745W5
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2025

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: 705.13P
• Device Lot Number: 1745W5
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CENTURION VISION SYSTEM (ACTIVE SENTRY).
• Patient Sex: Unknown