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

Catalog Number	8065000297
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	06/24/2025
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).
Event or Problem Description
A physician reported that during femtosecond laser assisted cataract surgery in hydro dissection step the patient has experienced capsular tear at the original rhexis edge.The surgery was proceeded with a three piece intraocular lens placement.The patient outcome was unknown.This complaint is pertaining the one of two reports received from the initial reporter.
Additional Manufacturer Narrative
Additional information is provided in sections h.6 and h.11.Service history was reviewed for the system.There was no service record (relevant to the reported event), found.All surgical systems are verified to meet specifications after installation and customer initiated servicing in accordance with the applicable procedure.The event occurrence was confirmed to have been unrelated to the use of the console.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.The event occurrence was confirmed to have been unrelated to the use of the console.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: 22539945
• Report Number: 2028159-2025-01043
• Device Sequence Number: 8028708
• Product Code: HQC
• UDI-Device Identifier: 00380650002976
• UDI-Public: (01)00380650002976(17)350603(11)250605(10)17F77M
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2025

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: 8065000297
• Device Lot Number: 17F77M
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 11/28/2025
• Date Device Manufactured: 06/05/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown