BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL

    MDR report key: 16565898 · Received March 17, 2023

    Report

    Report Number
    1119421-2023-00484
    Event Type
    Injury
    Date Received
    March 17, 2023
    Report Date
    March 17, 2023
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    MJP
    UDI-DI
    00380652455329
    PMA / PMN Number
    P190018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE 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, THE PATIENT HAD THE BEST VISION HE EVER HAD AT NEAR BUT DIFFICULTY SEEING AT DISTANCE. SURGEON RECOMMENDED HE GET -0.75 GLASSES TO SEE IF IT HELPED. THE PATIENT ENDED UP TRYING -1.00 AND COULD SEE CLEARLY. SURGEON DETERMINED PATIENT NEEDED A DIFFERENT IOL POWER SO SCHEDULED AN EXCHANGE. BUT UNABLE TO DO EXCHANGE SO DID A PIGGY BACK IOL WITH NON COMPANY -1.50 D LENS. AFTER THAT, THE PATIENT HAD DIFFICULTY SEEING AT NEAR AND HAS A LIGHT THAT COMES IN THE SIDE OF HIS EYE WHEN HE WAS APPROACHING A LIGHT SOURCE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559187 CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LLC - HUNTINGTON CCWET3 15346127 00380652455329

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention