BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX

    MDR report key: 5461051 · Received February 22, 2016

    Report

    Report Number
    MW5060500
    Event Type
    Injury
    Date Received
    February 22, 2016
    Date of Event
    February 17, 2016
    Report Date
    February 22, 2016
    Manufacturer
    ALCON/NOVARTIS
    Product Code
    LPM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I OPENED A NEW PACKAGE OF ALCON AIR OPTIX MULTIFOCAL LENSES AND USED 2 LENSES FROM THE PACKAGE. WITHIN 2 MINUTES, MY EYES BEGAN TO FEEL IRRITATED. WITHIN AN HOUR, BOTH EYES WERE GROSSLY REDDENED, IRRITATED, AND DISCHARGING A SMALL AMOUNT OF MUCOID DRAINAGE. I HAVE USED THIS PRODUCT FOR SEVERAL YEARS WITHOUT INCIDENT. THE PACKAGE I OPENED WAS RECENTLY ORDERED FROM LENS.COM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109416 AIR OPTIX AIR OPTIX LPM ALCON/NOVARTIS 846566702756 10257916

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR