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

Catalog Number	8065751763
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Eye Burn (2523); Intraocular Pressure Decreased (4468); Insufficient Information (4580)
Date of Event	06/03/2026
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 sculpting of nucleus, there was an occlusion of phacoemulsification tip with viscoelastic causing heat to disperse to main incision and the patient experienced corneal burn, collapsing of the anterior chamber, astigmatism and wound leakage and which requires sutures during cataract surgery (with intraocular lens implant).The surgery was completed on the same day with sutures of main wound.The patient symptoms were resolved.This is the one of two patients report received from the same facility.This report pertains to ophthalmic system involved for this event.

• 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: 25715885
• Report Number: 2028159-2026-00980
• Device Sequence Number: 5141683
• Product Code: HQC
• UDI-Device Identifier: 00380657517633
• UDI-Public: (01)00380657517633(17)261006(11)161005(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K121555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/06/2026

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: 8065751763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 07/06/2026
• Date Device Manufactured: 10/05/2016
• 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.; HAND PIECE.; UNSPECIFIED OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Male