MAUDE Adverse Event Report: ALCON GRIESHABER AG FINESSE REFLEX DSP FORCEPS; FORCEPS, OPHTHALMIC

Catalog Number	811.13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that an ophthalmic forceps tip broke off on the patient's eye during vitrectomy surgery.The tip was removed from the eye and the procedure was completed on same day.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 provided in sections h.6., and h.11.A review of the device history record (dhr) traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.A review of the database for the non-conformance events and the complaints showed that the given lot number was not concerned by any deviation and that there are no further complaints associated with the given lot.The concerned instrument was not received at the investigation site for evaluation.Therefore, no further assessment is possible and the investigation is concluded without identifying the root cause.The concerned instrument was not received at the manufacturing site which is why the root cause for the customer complaint issue cannot be determined.The exact root cause for the customer's reported event is unknown.Therefore, specific action cannot be taken.Complaints are reviewed and monitored at regular intervals for adverse trends.No adverse trends have been observed associated with the reported product and event.No action has been identified for this reported event.The manufacturer internal reference number is: (b)(4).

• Brand Name: FINESSE REFLEX 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: 21176785
• Report Number: 3003398873-2025-00011
• Device Sequence Number: 8603420
• Product Code: HNR
• UDI-Device Identifier: 07612717071575
• UDI-Public: (01)07612717071575(17)270430(11)240529(10)16UYF3
• 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,Followup
• Report Date (Section B): 04/21/2025

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: 811.13
• Device Lot Number: 16UYF3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 04/21/2025
• Date Device Manufactured: 05/29/2024
• 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