MAUDE Adverse Event Report: ALCON GRIESHABER AG FINESSE FLEX LOOP DSP; SPATULA, OPHTHALMIC

Catalog Number	338.25P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during surgery, the loop of the ophthalmic scraper detached and fell onto the fundus.The surgery was completed the same day after replacing the product with another one and there was no patient harm.
Additional Manufacturer Narrative
A sample has been received by manufacturing that has not yet been evaluated.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.The returned instrument was received in an outer blister, which is not a part of the instrument.The tyvek foil, showing the lot information was included as well.The product shows macroscopic signs of damage: it is evident, that the loop is broke off.It shows no signs of surgery residues.The instrument was visually inspected with the aid of a photomicroscope using various magnification, which confirmed that the loop broken off.The broken piece was also returned.As the blister was opened by the customer, the product was handled.Therefore, the point in time when the malfunction occurred can no longer be determined, nor can the strain put on the device be reconstructed.The customer¿s complaint is confirmed, but a root cause cannot be determined.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.No root cause for the customers reported event could be determined, since the situation that lead to the instrument failure cannot be reconstructed.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.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 FLEX LOOP DSP
• Common Device Name: SPATULA, 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: 23365381
• Report Number: 3003398873-2025-00396
• Device Sequence Number: 15983189
• Product Code: HND
• UDI-Device Identifier: 07612717071445
• UDI-Public: (01)07612717071445(17)270930(11)241024(10)1743YU
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 338.25P
• Device Lot Number: 1743YU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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