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

Catalog Number	8065000297
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that an ophthalmic console exhibited chamber instability following a software update.The surgery was completed during the same session.Information regarding the procedure details and any patient impact was not provided.Additional information has been requested; however, it is not available at the time of this report.
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 CS 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: 50567769
• Report Number: 2028159-2026-01373
• Device Sequence Number: 10495496
• Product Code: HQC
• UDI-Device Identifier: 00380650002976
• UDI-Public: (01)00380650002976(17)351116(11)251118(10)17RVUN
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: 8065000297
• Device Lot Number: 17RVUN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/08/2026
• Initial Report FDA Received Date: 09/02/2026
• Date Device Manufactured: 11/18/2025
• 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