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	02/27/2025
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported ophthalmic forceps broken during surgery while being used anteriorly; the broken piece of forceps was found in the eye, and the procedure was completed on the same day with the other forceps.And there was no patient harm reported.
Additional Manufacturer Narrative
Additional information received provided in sections h6 and h11.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 is one additional complaints associated with it.The provided images show the lot information of the instrument as well the a the tip of the product, where it is visible that one forceps arm broke off.However, the breaking site is not shown in detail, which is why the images do not indicate a root cause for the reported event.The concerned sample 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.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.The associated product was not received at the investigation site.Therefore, the root cause for the customer complaint issue cannot be determined conclusively.Based on the complainant's statement regarding grasping an iol haptic and the product's directions for use (dfu) defining that the products are "intended to be used in vitreoretinal surgery for grasping or cutting of intraocular tissues", it is concluded that the product was used outside of its intended use.The investigation is completed based on this information, determining use error as the root cause for the reported event.Not warranted: as the root cause and its origin are inconclusive, further investigative or manufacturing actions are not warranted at this time.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.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: 21716466
• Report Number: 3003398873-2025-00246
• Device Sequence Number: 9941786
• 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): 06/23/2025

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: 02/28/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 06/23/2025
• 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