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

Catalog Number	725.13P
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned instrument was received in its inner blister.The outer blister and the tyvek foil were missing.The device shows no macroscopic sign of damage but there are surgery residues.The instrument was visually inspected with the aid of photomicroscope using various magnification.During the visual inspection, no abnormalities could be identified.The instrument was then functionally tested.The forceps arms opened and closed as expected and the grasping arms shows no bending, and no misalignment was found.Therefore, the customer's complaint could not be confirmed.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.A root cause for the customers reported event could not be determined because the returned product met manufacturer¿s specifications.No action was taken as the returned sample met specifications for tests performed in relation to the reported event.Complaint data for all products is reviewed monthly to monitor for adverse trends.During the last review, no observation 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 physician reported that during the vitrectomy surgery an ophthalmic forceps did not open and close properly.The surgery was completed by replacing the product with another one.No patient impact was reported.

• Brand Name: GRIESHABER MAXGRIP ADVANCED DSP TIP 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: 23618292
• Report Number: 3003398873-2025-00418
• Device Sequence Number: 9032196
• Product Code: HNR
• UDI-Device Identifier: 07612717071155
• UDI-Public: (01)07612717071155(17)271231(11)250113(10)1778VN
• 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
• Report Date (Section B): 11/21/2025

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: 725.13P
• Device Lot Number: 1778VN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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 Sex: Unknown