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

Catalog Number	8065000565
Medical Device Problem Codes	Improper Flow or Infusion (2954); Noise, Audible (3273)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction

• 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 ; +1(800)757-9780
• MDR Report Key: 50207439
• Report Number: 2028159-2026-01265
• Device Sequence Number: 5482561
• Product Code: HQC
• UDI-Device Identifier: 00380650005656
• UDI-Public: (01)00380650005656(17)340410(11)240412(10)16PKNN
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121555
• 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
• Report Date (Section B): 08/11/2026

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: 8065000565
• Device Lot Number: 16PKNN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/11/2026
• Date Device Manufactured: 04/12/2024
• 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
• Patient Sex: Female