BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1-DAY ACUVUE MOIST

    MDR report key: 5658697 · Received May 12, 2016

    Report

    Report Number
    MW5062265
    Event Type
    Malfunction
    Date Received
    May 12, 2016
    Date of Event
    May 9, 2016
    Report Date
    May 12, 2016
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    JNJ 1-DAY ACUVUE MOIST, LOT #: [30320001]06 0000014. I HAVE BEEN USING THIS BRAND OF LENS FOR OVER 5 YEARS, WEARING CONTACTS FOR 16 YEARS. THE CONTACT LENSES WERE PACKAGED INSIDE OUT. WHEN I PUT THE LENS IN MY EYE, THERE WAS IMMEDIATE ITCHING. I REMOVED, CLEANED AND REINSERTED. THE LENS FELL OUT APPROXIMATELY 2.5 HOURS LATER AND NEVER FELT PROPERLY SEATED. WHEN I CLEANED AND PUT BACK IN, I EXPERIENCED IMMEDIATE REDNESS, ITCHING AND TEARING. I THREW THE LENS AWAY AND REPLACED WITH ANOTHER FROM THE SAME PACKAGE. THIS EXPERIENCE HAS REPEATED WITH DIMINISHED SEVERITY OVER THE PAST 5 DAYS. THE LENSES FREQUENTLY FALL OUT OR GET CAUGHT BEHIND MY EYELID UPON BLINKING. THE RIGHT EYE USES A DIFFERENT PRESCRIPTION/LOT AND HAS NOT EXPERIENCED PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304913 1-DAY ACUVUE MOIST 1-DAY ACUVUE MOIST LPL JOHNSON & JOHNSON -2.50D [30320001]06 00000145

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR