BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM

    MDR report key: 22321757 · Received June 24, 2025

    Report

    Report Number
    9612169-2025-01282
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    May 28, 2025
    Report Date
    September 8, 2025
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652393799
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE LENS REMAINS IMPLANTED. 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).

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION HAS BEEN PROVIDED IN H.6., AND H.11. CORRECTION: ON INITIAL MDR, THE PRODUCT SHOULD BE A2201 INSTEAD OF A040604. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A FACILITY REPRESENTATIVE REPORTED THAT THE LEADING HAPTIC UPON IMPLANTATION WAS TUCKED UNDERNEATH THE OPTIC. IMPLANTED LENS WITHOUT COMPLICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568261 CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. CNA0T0 25963511 00380652393799

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female DUOVISC VISCOELASTIC SYSTEM.