BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOHNSON & JOHNSON

    MDR report key: 1220906 · Received October 31, 2008

    Report

    Report Number
    MW5008867
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 31, 2008
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ACUVUE ADVANCE WITH HYDRACLEAR CAUSED AN ALLERGIC REACTION IN MY EYES. I HAD NEVER HEARD OF THIS HAPPENING BEFORE AND MY DOCTOR HAD NEVER EVEN MENTIONED IT WAS POSSIBLE. I HAVE BEEN WEARING CONTACTS SINCE I WAS 13 AND HAVE NEVER HAD A PROBLEM BEFORE. THESE CONTACTS CAN CAUSE YOUR EYES TO SWELL AND TO DISCHARGE. BECAUSE I HAD NO IDEA AN ALLERGIC REACTION WAS POSSIBLE, I KEPT WEARING THEM. I TOOK THEM OUT AFTER A FEW HOURS WHEN MY EYES STARTED GETTING REALLY ITCHY, BUT PUT THEM BACK IN LATER. THEN I NOTICED THE BUMPS FORMING UNDER MY EYELIDS. I WENT TO THE DOCTOR AND HE SAID THEY WERE STYES WITHOUT EVEN LOOKING AT THEM. AFTER THE PRESCRIPTION, HE PRESCRIBED DIDN'T WORK, I WENT BACK. I SHOWED HIM WHAT THEY LOOKED LIKE AND HE SAID IT WAS ACTUALLY CHALAZIA. I STARTED LOOKING ON THE INTERNET FOR INFO ABOUT THE ACUVUE ADVANCE CONTACTS, AND THERE ARE FORUMS OF PEOPLE TRYING TO FIGURE OUT WHAT IS WRONG WITH THEIR EYES. EVERYONE HAVING TROUBLE IS SUSPICIOUS OF THE CONTACTS, BUT NO ONE KNOWS WHAT TO DO. THERE IS SIMPLY NO INFO OUT THEIR TELLING PEOPLE THE RISK OF THESE CONTACTS OR WHAT TO DO IF THEY EXPERIENCE SYMPTOMS. SINCE I STOPPED WEARING THEM, THE ALLERGIC REACTION WENT AWAY, BUT THE CHALAZIA WILL TAKE A LONG TIME TO HEAL. ROUTE: UNK. DATES OF USE: 2008. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES. DIAGNOSIS OR REASON FOR USE: CORRECTIVE VISION. EVENT REAPPEARED AFTER REINTRODUCTION? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOHNSON & JOHNSON ACUVUE ADVANCE WITH HYDRACLEAR LPL

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other