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

Catalog Number	8065752914
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that patients developed toxic anterior segment syndrome (tass) following a procedure involving an ophthalmic handpiece.Procedure details and current condition of patients have not been provided.Additional information has been requested but is not available at the time of this report.Additional information received indicated that a cataract procedure on the right eye had been scheduled.
Additional Manufacturer Narrative
G.8.This report originally filed as 2523835-2026-00814 (mdr# (b)(6)).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, Accessory, Active Sentry Handpiece
• 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: 50815342
• Report Number: 2028159-2026-01481
• Device Sequence Number: 10697031
• Product Code: HQC
• UDI-Device Identifier: 00380657529148
• UDI-Public: (01)00380657529148(17)320507(11)220510(10)14NA3L
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065752914
• Device Lot Number: 14NA3L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 05/10/2022
• 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: Other
• Patient Sex: Unknown