BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON PANOPTIX PRO TRIFOCAL UV ABSORBING IOL W/AUTONOME DELIVERY SYSTEM

    MDR report key: 22559649 · Received July 21, 2025

    Report

    Report Number
    9612169-2025-01430
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Report Date
    July 21, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380658490294
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, EXPLANTED IOL WITH REASON WRONG AXIS. CLINICAL REASON FOR THE EXPLANT IS IOL NOTED TO BE SUBLUXED INFERIORLY. THE LENS WAS REPLACED WITH DIFFERENT MODEL COMPANY LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING AS PER THE SURGEON OPINION PATIENT HAD BEEN A RESTLESS SLEEPER SINCE SURGERY AND REPORT IT IS POSSIBLE, HE ACCIDENTALLY RUBBED OR MANIPULATING EYE HAS CONTRIBUTED TO THE CAUSE OF EVENT. PATIENT SYMPTOMS WERE STILL CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2036780 CLAREON PANOPTIX PRO TRIFOCAL UV ABSORBING IOL W/AUTONOME DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. PXCAT0 25990792 00380658490294

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ORA SYSTEM.| PROVISC.