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

Catalog Number	338.27
Medical Device Problem Codes	Break (1069); Activation Problem (4042)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2026
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 physician reported that during surgery, an ophthalmic loop had actuation problem.The surgery was completed on the same day.Details of patient impact was not reported.Additional information has been requested but is not available at the time of this report.Additional information was received reporting that the actual issue was that the loop failed to retract properly into the needle along with the loop broken outside the eye.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.The returned instrument was received in its outer blister, covered with the tyvek lid foil showing the lot information.The broke off loop was stick with an adhesive tape on the blister.The instrument and the loop were visually inspected with the aid of a photomicroscope using various magnifications.The fractured surfaces do not show any abnormalities that would indicate a root cause for the breakage.The situation in which the defect 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.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: 24558364
• Report Number: 3003398873-2026-00056
• Device Sequence Number: 15686598
• Product Code: HND
• UDI-Device Identifier: 07612717071452
• UDI-Public: (01)07612717071452(17)280630(11)250707(10)17J388
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: 338.27
• Device Lot Number: 17J388
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2025
• 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