BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM

    MDR report key: 20322958 · Received September 27, 2024

    Report

    Report Number
    9612169-2024-00969
    Event Type
    Injury
    Date Received
    September 27, 2024
    Report Date
    September 27, 2024
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380652393713
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, 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).

    Description of Event or Problem · 0

    A NON HEALTH CARE PROFESSIONAL REPORTED THAT AFTER SURGERY, THE PATIENT EXPERIENCED HALOS, STARBURSTS, GLARE, CRESCENTS IN PERIPHERAL VISION, CANNOT DRIVE AT NIGHT AND SEES AURAS AROUND LIGHTS. ALSO PATIENT EYES LOOKS LIKE A CAT EYE BECAUSE IT GLOWS. ADDITIONAL INFORMATION HAVE RECEIVED IT STATES THAT THE PATIENT HAD AN EXTENSIVE TESTING USING VERY BRIGHT LIGHTS. THIS WAS EXTREMELY UNCOMFORTABLE FOR HER EYE WITH THE NEW REFLECTIVE LENS, DEVELOPED A HEADACHE AND FELT UNWELL FOR SEVERAL DAYS. THE RESULTS OF THE TESTS WERE ALL GOOD, NO PROBLEMS WITH HER EYES. DOCTOR TOLD HER THAT SECOND SURGERY TO REPLACE THE NEW LENS WOULD BE IMPOSSIBLE. IT WAS TOO RISKY AND NOT USUALLY EVER DONE. PATIENT VISION WAS AFFECTED NEGATIVELY EVERY DAY BECAUSE OF THE NEW LENS. IT WAS SO MUCH BETTER BEFORE THE IMPLANTATION. NO REFLECTIVE ISSUES AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1432957 CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. CNA0T0 25652862 00380652393713

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other