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	08/27/2025
Type of Reportable Event	Malfunction
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.A sample is available that has not yet been received at manufacturing for evaluation.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported that an ophthalmic forceps was broken during the surgery surgeon noticed the forceps broken after being put back through the trocar and foreign body was removed.Surgery was completed on the same day.There was no patient impact.
Additional Manufacturer Narrative
Additional information provided in section d.3, d.9, h.6 and h.11.The returned instrument was received in outer blister, covered with the tyvek lid foil showing the lot information.The inner blister which protects the instrument during the shipment, was not used.The product evidently shows macroscopic signs of damage, namely that the forceps arms are broken off and the tube is significant bent.The instrument was visually inspected with the aid of a photomicroscope under various magnifications.The visual inspection shows the broke off forceps in detail.Since the instrument was insufficient protected during the shipment from the complainant to the investigation site and the tube deformation and that both forceps arms are broke off, is not described in the initial report, it is assumed that these damages occurred during the shipment.The situation in which the malfunction 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.Non-conformance report provided by originator.A non-conformance based review of the lot number was performed and did not reveal any potential contributing factors to the reported complaint since it was reported that the defect occurred during use of the instrument outside of its intended use, the root cause is identified as "external - use error".The originator reported that the surgeon was "performing a scleral fixed lens procedure" with the associated product.The product's directions for use (dfu) states that they are "intended to be used in vitreoretinal surgery for grasping or cutting of intraocular tissues".It is therefore concluded that the product was used outside of its intended use and the investigation is completed based on this information.No actions are required since the defect occurred during use for a purpose not covered by its intended use, which is communicated in the product's dfu.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).

• 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: 23578138
• Report Number: 3003398873-2025-00415
• Device Sequence Number: 18488960
• Product Code: HNR
• UDI-Device Identifier: 07612717071575
• UDI-Public: (01)07612717071575(17)270131(11)240216(10)16JXNH
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 16JXNH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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: Female