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	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during demonstration of vitrectomy handpiece it was to found be not working.Procedure was completed by other machine.No patient harm was reported.
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
Additional information was provided in section b.5.Correction information was provided in section e.1.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received indicated that the event happened during cataract surgery.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.The company representative was able to replicate the reported water flow issue and the reported system message (sm) being displayed.To address both issues, the representative replaced to fluidics module.The fluidics module was returned for testing on this investigation.The system was tested and found to meet product specifications.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 with the same event code.The fluidics module was received for testing on this investigation.A visual assessment of the returned sample revealed a corroded zinc plate.The returned sample was connected to a calibrated system and started without any sm.The cassette was inserted and latched without any issues.The handpiece and probe passed priming and tuning.The returned fluidics module passed all functional testing.The returned fluidics module passed all surgical test modes without any issues.As such, the reported events could not be replicated.The returned fluidics module was determined to have been functioning.Therefore, the root cause of the reported ¿sm and the water flowing issue¿ were both determined inconclusive.The root cause of the reported ¿sm and the water flowing issue¿ were both determined inconclusive.Manufacturer will continue to monitor data 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: 22296399
• Report Number: 2028159-2025-00905
• Device Sequence Number: 12992309
• Product Code: HQC
• UDI-Device Identifier: 00380657530502
• UDI-Public: (01)00380657530502(17)290201(11)190204(10)NA
• Combination Product (Y/N): N
• PMA/510(K) Number: K191650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2025

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: 8065753050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 09/12/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/31/2025; 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2019
• 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