MAUDE Adverse Event Report: Alcon Grieshaber AG GRIESHABER REVOLUTION DSP Forceps; Forceps, Ophthalmic

Catalog Number	705.43P
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during a right eye vitrectomy, the tips of the ophthalmic forceps remained in the locked position even when the surgeon was not depressing the handle during an intraocular lens exchange procedure.The surgeon opened a second forceps but it also became stuck in the locked position.Two forceps received from same lot number.As a result, a third forceps was opened and successfully used to complete the procedure.The surgery was completed using a total of three end grasping forceps, and no patient harm was reported.This report is pertaining to first of two reports received from the initial reporter.
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).

• 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 ; +1(800)757-9780
• MDR Report Key: 50819592
• Report Number: 3003398873-2026-00199
• Device Sequence Number: 18692461
• Product Code: HNR
• UDI-Device Identifier: 07612717070677
• UDI-Public: (01)07612717070677(17)290228(11)260326(10)180YW2
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/18/2026

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: 705.43P
• Device Lot Number: 180YW2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 03/26/2026
• 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: 77 YR
• Patient Sex: Male