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

Catalog Number	8065000296
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	06/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that there was display of error code during cataract surgery (with intra ocular lens implantation) surgery in the right eye of a male elderly patient.The incident resulted in prolonged delay in the start and progression of the surgical procedures causing anxiety in patient requiring supplemental sedation and oxygen therapy, as well as delaying their postoperative discharge.Although inpatient admission was not required; management was outpatient-based and the patient was prescribed with topical ophthalmic drops per standard post-cataract surgery protocol.There was no negative consequences on the patient and the patient was recovering.This report pertains to ophthalmic console involved for this reported event.
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: 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: 50210792
• Report Number: 2028159-2026-01271
• Device Sequence Number: 14977177
• Product Code: HQC
• UDI-Device Identifier: 00380650002969
• UDI-Public: (01)00380650002969(17)360210(11)260212(10)17WK92
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233876
• 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
• Report Date (Section B): 09/09/2026

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: 8065000296
• Device Lot Number: 17WK92
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/18/2026
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 02/12/2026
• 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: BSS Sterile Irrigating Solution.; Hand Piece.; UNITY Cataract FMS Procedure Pack.; UNITY TOTAL PLUS Combined Procedure Pack.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male