MAUDE Adverse Event Report: Alcon Research, LLC - Irvine Technology Center LEGION System; Unit, phacofragmentation

Catalog Number	8065753075
Medical Device Problem Code	Failure to Back-Up (1047)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that an ophthalmic console used for the cataract surgery user experienced the settings issue.The patient experienced posterior capsular tear during the quad procedure.No vitrectomy was required.The surgeon was able to proceed with single piece intraocular implantation and no medical intervention required.The current outcome of the patient condition was unknown.Additional information has been requested but is not available at the time of this report.This complaint pertains to ophthalmic system involved in the reported events.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: LEGION System
• 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 ; +1(800)757-9780
• MDR Report Key: 50078746
• Report Number: 2028159-2026-01167
• Device Sequence Number: 10719464
• Product Code: HQC
• UDI-Device Identifier: 00380657530755
• UDI-Public: (01)00380657530755(17)350826(11)250828(10)17LAX6
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065753075
• Device Lot Number: 17LAX6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 07/30/2026
• Date Device Manufactured: 08/28/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LEGION Active Sentry Handpiece; LEGION FMS Pack
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown