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	02/12/2026
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
The customer reported that a during vitreoretinal surgery an ophthalmic scraper loop was broken.The surgery was completed on the same day by using new device.There was no patient impact.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.The returned instrument was received at the manufacturing site in its inner and outer blister, covered with the tyvek lid foil showing the lot information.The product was returned with the loop in retracted state and shows no macroscopic signs of damage but a few signs of surgery residues.Functional testing showed that the retraction and protraction mechanism was in working condition.The instrument was visually inspected with the aid of a photomicroscope with various magnifications, however, when the loop was extended, it was noticed that it had broken.As the blister was opened by the customer, the product was handled.Therefore, the point in time when the defect on the loop 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 for the breakage cannot be determined.A review of the device history record traceable to the reported lot number indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.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 customer's 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 manufacture 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: 24530593
• Report Number: 3003398873-2026-00054
• Device Sequence Number: 9026842
• Product Code: HND
• UDI-Device Identifier: 07612717071445
• UDI-Public: (01)07612717071445(17)280630(11)250710(10)17J8WV
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 04/22/2026

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: 338.25P
• Device Lot Number: 17J8WV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• 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