MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER UNITY CS CONSOLE; UNIT, PHACOFRAGMENTATION

Catalog Number	8065000297
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information received provided in sections h.6., and h.11.A non-conformance-based review of the batch/lot/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 of complaints reported against this lot/batch/serial number was performed.No similar complaints were reported regarding the product lot/batch/serial under investigation.A review of service records relevant to the reported complaint was performed.No service records relevant to the reported complaint were found.No photo(s) and/or video(s) was provided for evaluation by the reporter, and a sample was not received at the investigation site for evaluation.The reported complaint was evaluated and does not meet criteria for reporting per applicable medical device regulations, does not meet criteria for a critical event, and a customer response was not requested.A review of production information, complaint history, and service (as applicable) was carried out and did not reveal any potential contributing factors to the complaint.A complaint sample, photo, and/or video were not provided for evaluation.Based on the investigation, a failure of the device, labeling, or packaging to meet specifications could not be confirmed.Quality assurance has evaluated and investigated this complaint.Complaints are reviewed and monitored for adverse trends monthly and manufacturers will continue to monitor data for evidence of adverse trending and take further action, if appropriate.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during cataract surgery, the ophthalmic console displayed a high irrigation system message, and a notification appeared on the screen indicating that all fluidics were suspended, with no irrigation, no aspiration, and a break in occlusion.This issue was triggered by wound leakage in the patient.The surgery was completed on the same day, and information regarding patient impact has not been provided.

• 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 ; 8007579780
• MDR Report Key: 24696322
• Report Number: 2028159-2026-00380
• Device Sequence Number: 10151770
• Product Code: HQC
• UDI-Device Identifier: 00380650002976
• UDI-Public: (01)00380650002976(17)351025(11)251027(10)17PWTT
• 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,Followup
• Report Date (Section B): 05/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065000297
• Device Lot Number: 17PWTT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 05/29/2026
• Date Device Manufactured: 10/27/2025
• 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