MAUDE Adverse Event Report: Alcon Research, LLC - Irvine Technology Center UNITY VCS Console; Unit, phacofragmentation

Catalog Number	8065000296
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that an ophthalmic system exhibited no ultrasonic oscillation during surgery.The surgery was completed on the same day after the system was restarted and normal function was restored.The surgeon declined to provide any additional information.
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).

• Brand Name: UNITY VCS Console
• 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: 50931168
• Report Number: 2028159-2026-01534
• Device Sequence Number: 10725344
• Product Code: HQC
• UDI-Device Identifier: 00380650002969
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K233876
• 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
• Report Date (Section B): 09/29/2026

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: 8065000296
• Device Lot Number: 17KHUK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 08/13/2025
• 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
• Patient Sex: Unknown