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

Catalog Number	8065000297
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Codes	Corneal Scar (1793); Eye Burn (2523)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
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).H10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A nurse reported that patient experienced wound burn, corneal injury and corneal opacity stitches required.Drop has been prescribed post surgery.Ophthalmic system and handpiece exhibited no aspiration during the sculp mode ophthalmic system and also displayed system message.
Additional Manufacturer Narrative
Service history was reviewed for the system.There were no service records (relevant to the reported event), found.However, the system was last serviced prior to the reported event per service record (sr).The system was found to meet all cosmetic and performance standards.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.There were no relevant complaints found as part of this investigation.The potential cause of a corneal burn can be attributed to surgical mitigations or factors.By proactively implementing preventive strategies to optimize surgical outcomes, surgeons will prioritize patient safety during msics procedures.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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 24530730
• Report Number: 2028159-2026-00285
• Device Sequence Number: 13349925
• Product Code: HQC
• UDI-Device Identifier: 00380650002976
• UDI-Public: (01)00380650002976(17)351122(11)251124(10)17TP4K
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K233876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

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: 17TP4K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACTIVE SENTRY HANDPIECE; UNITY CATARACT FMS PROCEDURE PACK
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown