MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Catalog Number	8065751763
Medical Device Problem Codes	Accessory Incompatible (1004); No Device Output (1435); Improper Flow or Infusion (2954); Pressure Problem (3012)
Health Effect - Clinical Code	Intraocular Pressure Decreased (4468)
Date of Event	03/24/2026
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).H.10 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 during cataract surgery, phacoemulsification stopped mid case in an ophthalmic system.The system displayed a system message and ejected the fluidics management system (fms).The patient experienced eye collapse and required sutures.The surgery was completed on the same day after restarting the system with a new fms and a balanced salt solution bag.The patient¿s current condition was unknown.This report pertains to ophthalmic system involved for this reported event.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.The company representative was able to confirm the system message (via event log review).However, the reported intraocular pressure (iop) and phaco issues were not able to be replicated (while on-site).The system was tested and found to meet product specifications.Therefore, the root cause of the reported issues are 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 similar complaints reported for the ¿product serial¿ under investigation, with the same event code.The potential root cause of the reported system message (sm) codes, being displayed (depend upon occurrence) but are used as a mitigation tool, to help advance the issues that come up, with the submodules.While the sm codes were confirmed, the system was found to have no problems.The system was found to have no problems.Therefore, the root cause of the reported issues remains 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: CENTURION VISION SYSTEM
• 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: 24895834
• Report Number: 2028159-2026-00510
• Device Sequence Number: 9271890
• Product Code: HQC
• UDI-Device Identifier: 00380657517633
• UDI-Public: (01)00380657517633(17)270720(11)170720(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K121555
• 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): 07/17/2026

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: 8065751763
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2017
• 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: CENTURION SURGICAL PROCEDURE PAK
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown