MAUDE Adverse Event Report: Alcon Research, LLC - Irvine Technology Center CENTURION Vision System (Active Sentry); Unit, phacofragmentation

Catalog Number	8065753057
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Intraocular Pressure Decreased (4468)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that during the cataract surgery using an ophthalmic system, the vacuum/aspiration seemed normal but the irrigation abruptly turned off while removing the last nuclear quadrant, the anterior chamber collapsed and got a hole in my posterior capsule and resultant anterior vitrectomy, a single piece intraocular lens (iol) was inserted.Procedure details were unknown.The current condition of patient was unknown.This report pertains to an ophthalmic system involved for this complaint.
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.

• Brand Name: CENTURION Vision System (Active Sentry)
• 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 ; +1(800)757-9780
• MDR Report Key: 50177261
• Report Number: 2028159-2026-01257
• Device Sequence Number: 15922811
• Product Code: HQC
• UDI-Device Identifier: 00380657530571
• UDI-Public: (01)00380657530571(17)310330(11)210401(10)13UTEH
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161794
• 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): 08/31/2026

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: 8065753057
• Device Lot Number: 13UTEH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/16/2026
• Supplement Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 04/01/2021
• 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