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

Catalog Number	8065000297
Medical Device Problem Codes	No Device Output (1435); Suction Problem (2170)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during phacoemulsification mode of surgery an ophthalmic system's phaco and aspiration completely stopped.The system was re-booted and re-primed to complete the case.Details related to patient harm was not reported.Additional information has been requested, none received till date.
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).
Additional Manufacturer Narrative
Additional information provided in sections h.6 and h.11.The customer reported having to "reboot and reprime/tune but was able to complete the case." servicing was subsequently cancelled (without additional information provided).The company representative did not test the system (on-site).However, the customer did report they were able to reboot successfully.Based on the information obtained, the root cause of the reported event is inconclusive.A non-conformance based review of the 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 for ¿complaints reported against this serial number¿ was performed.All relevant complaints found were reviewed as part of this investigation.Based on the information obtained, the root cause of the reported event is inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.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 ; 8007579780
• MDR Report Key: 24035665
• Report Number: 2028159-2026-00057
• Device Sequence Number: 13025999
• Product Code: HQC
• UDI-Device Identifier: 00380650002976
• UDI-Public: (01)00380650002976(17)351022(11)251024(10)17PWT6
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K233876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: 17PWT6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 04/16/2026
• Date Device Manufactured: 10/24/2025
• 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