MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION Vision System, Accessory, CENTURION OZIL Handpiece; UNIT, PHACOFRAGMENTATION

Catalog Number	8065751761
Medical Device Problem Codes	No Device Output (1435); Suction Problem (2170); Excessive Heating (4030)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Corneal Pannus (1447); Corneal Scar (1793); Visual Impairment (2138); Eye Burn (2523); Intraocular Pressure Decreased (4468)
Date of Event	05/04/2026
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 physician reported that during a femtosecond-assisted cataract extraction with intraocular lens implantation procedure on the left eye, after insertion of the phacoemulsification tip, no aspiration or phacoemulsification effect was observed and a corneal thermal injury was noted within seconds during the pre-sculpting phase before entering the nucleus.The physician reported that irrigation was functioning prior to insertion of the ophthalmic handpiece into the eye and no occlusion tone was heard.In the surgeon¿s opinion, extra heat buildup at the phacoemulsification tip contributed to the event.The thermal injury resulted in wound gaping and leakage.The ophthalmic handpiece, tubing, and cassette were exchanged, and the procedure was completed successfully on the same day.The incision was closed with ophthalmic sutures, and tissue adhesive was applied due to wound leakage.Postoperatively, mild anterior chamber shallowing, postoperative astigmatism, mild corneal opacity, and temporal corneal neovascularization were reported.The adhesive was removed and reapplied, and no further leak was reported.Follow-up treatment for astigmatism and possible release of a temporal iridocorneal adhesion was planned.The current condition of the patient was unknown.This report pertains to ophthalmic handpiece involved for this reported event.

• Brand Name: CENTURION Vision System, Accessory, CENTURION OZIL 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 ; 8007579780
• MDR Report Key: 25908268
• Report Number: 2028159-2026-01143
• Device Sequence Number: 14937704
• Product Code: HQC
• UDI-Device Identifier: 00380657517619
• UDI-Public: (01)00380657517619(17)330315(11)230318(10)15ETXK
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2026

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: 8065751761
• Device Lot Number: 15ETXK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2026
• Supplement Report FDA Received Date: 08/21/2026
• Date Device Manufactured: 03/18/2023
• 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; PHACO TIP
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Male