MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LEGION ANTERIOR VITRECTOMY HANDPIECE; UNIT, PHACOFRAGMENTATION

Catalog Number	8065753050
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2025
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 that during cataract surgery, the ophthalmic handpiece was not cutting and displayed an advisory code.The surgery was completed manually using forceps, without the use of a vitrectomy cutter.There was no patient contact or harm.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.However, a vit cutter was returned for testing on this investigation.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.The vit cutter was received for testing on this investigation.A visual assessment of the returned sample revealed a missing connector cap.The handpiece was connected to a calibrated breakout test box, where the resistance values were found to be within specification.The returned handpiece was connected to a calibrated system.The handpiece was recognized by the system.A system message (sm) was displayed when the handpiece attempted the pre-surgery vit test.A probe test was performed on the handpiece, which found the tip port did not move.Disassembling the handpiece revealed coil failure.However, how or when the coil became nonconforming remains inconclusive.The root cause of the reported event can be attributed to a nonconforming coil.However, how or when the coil became nonconforming remains inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Similar incident/event data was collected for the associated reported events.Quality assurance will continue to perform periodic monitoring for evidence of adverse trending and take further action as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: LEGION ANTERIOR VITRECTOMY HANDPIECE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23366784
• Report Number: 2028159-2025-01575
• Device Sequence Number: 9931951
• Product Code: HQC
• UDI-Device Identifier: 00380657530502
• UDI-Public: (01)00380657530502(17)310511(11)210513(10)13W8YY
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K191650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: 8065753050
• Device Lot Number: 13W8YY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown