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

Catalog Number	338.27
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that an ophthalmic operating flexible loop was found to be failed.The surgery was completed by an alternate product.There was no reports of patient harm.
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).
Additional Manufacturer Narrative
A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The investigation is completed based on the sample evaluation illustrated below.The sample was received in its inner and outer blister and the cover foil, showing the lot information.The sample shows no macroscopic signs of damage or of surgery residues.The sample was visually inspected with the aid of a photomicroscope using various magnifications.The visual inspection revealed no issues with the device, as the loop form as well as the teeth look undamaged.The device¿s actuation mechanism was working well, allowing to protract and pull in the loop as desired.Therefore, the returned device meets its acceptance criteria and the customer¿s complaint could not be confirmed.A root cause for the customers reported event could not be determined because the returned product met the manufacturer¿s specifications.No action was taken as the returned sample met specifications for tests performed in relation to the reported event.Complaints are reviewed and monitored at regular intervals for adverse trends.No adverse trends have been observed associated with the reported product and event.No action has been identified for this reported event.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: 18747459
• Report Number: 3003398873-2024-00020
• Device Sequence Number: 3837394
• Product Code: HND
• UDI-Device Identifier: 07612717071452
• UDI-Public: 07612717071452
• 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): 03/27/2024

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 338.27
• Device Lot Number: 160M10
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• 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