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

Catalog Number	711.13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Corneal Edema (1791); Inflammation (1932)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information provided in sections d.9, h.3, h.6 and h.11.The returned instrument was received in its outer blister, the inner blister which protects the device during shipment was not used and the tyvek foil was missing as well.The product shows macroscopic signs of damage, namely that both forceps arms are broken off and the tube is significant bent.There are sign surgery residues.The instrument was visually inspected with the aid of a photomicroscope with various magnifications.The visual inspection shows the tip in detail.There is no fractured surface for an assessment.The situation in which the defect occurred can no longer be reconstructed, nor can the strain put on the device be determined.Therefore, the customer¿s complaint is 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.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 customers reported event could be determined, since the situation that lead to the instrument 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.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).
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 the vitrectomy surgery one of an ophthalmic shank of the forceps was not attached and found on the retina next to macula.The surgeon managed to get the shank out of the eye.Due to longer surgery time the patient had postoperative inflammation and corneal edema.The surgery was completed with new forceps.The current condition of the patient was unknown.Additional information was requested.

• 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: 24145917
• Report Number: 3003398873-2026-00028
• Device Sequence Number: 15824377
• Product Code: HNR
• UDI-Device Identifier: 07612717071292
• UDI-Public: (01)07612717071292(17)270430(11)240523(10)16UCKP
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: 711.13
• Device Lot Number: 16UCKP
• 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: 12/31/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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