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

Catalog Number	705.44P
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during retinal surgery an ophthalmic forceps disassembled while the surgeon was peeling the internal limiting membrane.Parts of the forceps fell onto the retina and successfully retrieved the detached parts from the retina.The forceps were replaced with another unit.The surgery was completed on the same day.There was no patient harm.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 50818040
• Report Number: 3003398873-2026-00198
• Device Sequence Number: 21502177
• Product Code: HNR
• UDI-Device Identifier: 07612717070622
• UDI-Public: (01)07612717070622(17)281031(11)251113(10)17TDET
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• 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: 705.44P
• Device Lot Number: 17TDET
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 11/13/2025
• 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