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	Conjunctivitis (1784); Corneal Edema (1791); Endophthalmitis (1835); Hypopyon (1913); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that a 79-year-old female patient underwent phacoemulsification with intraocular lens (iol) implantation in the right eye with ophthalmic system , handpiece , custom pak , opthalmic lens were used.During a postoperative follow-up visit, the patient was diagnosed with endophthalmitis in the right eye.Clinical examination revealed associated signs and symptoms including hypopyon, aqueous fibrin and cellular reaction in the anterior chamber, corneal edema, and decreased visual acuity.In response to the event, the patient was treated with intravitreal antibiotic injections, steroids, and nonsteroidal anti-inflammatory drugs (nsaids).An anterior chamber tap was performed, and culture results were reported as no growth.At the time of reporting, the patient had not recovered.This report pertains to one of three patient for system issue from same facility.
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
• 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: 25772698
• Report Number: 2028159-2026-01010
• Device Sequence Number: 10252721
• Product Code: HQC
• UDI-Device Identifier: 00380657517633
• UDI-Public: (01)00380657517633(17)250423(11)150429(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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 Expiration Date: 04/23/2025
• 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: 06/11/2026
• Initial Report FDA Received Date: 07/09/2026
• Date Device Manufactured: 04/29/2015
• 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: Required Intervention; Other
• Patient Age: 79 YR
• Patient Sex: Female