BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUVUE OASYS WITH HYDRACLEAR PLUS

    MDR report key: 1040335 · Received May 8, 2008

    Report

    Report Number
    MW5006785
    Event Type
    Other
    Date Received
    May 8, 2008
    Date of Event
    May 25, 2007
    Report Date
    May 8, 2008
    Manufacturer
    VISTAKON, JOHNSON AND JOHNSON
    Product Code
    LPL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I BEGAN WEARING ACUVUE OASYS CONTACT LENSES IN 2006, AND THEY WERE GREAT! I HAD EYE STRAIN ISSUES RELATED TO EXTENDED COMPUTER USE, AND THEY REALLY HELPED. BUT THEN, A YEAR LATER IN 2007, I HAD MY PRESCRIPTION REFILLED, AND IN THE FOLLOWING 4 MONTHS OF USE, I SUFFERED FROM SWOLLEN LIDS, BLOODSHOT EYES, AND SENSITIVITY TO LIGHT, PLUS GUMMINESS AND SOME KIND OF DISCHARGE. I WENT TO MULTIPLE OPHTHALMOLOGISTS AND OPTOMETRISTS, WITH ONE WHO FINALLY NOTED THAT I HAD BUMPS UNDER MY EYELIDS, INDICATING AN ALLERGIC REACTION OF SOME KIND TO MY CONTACTS. I HAD BEEN DIAGNOSED WITH GPC, EKC, AND PRESCRIBED ZYLET. MY ORIGINAL OPTOMETRIST THEN SWITCHED ME TO FOCUS DAILIES - IN CASE THE PROBLEMS WERE CAUSED BY AN INFECTION. A YEAR LATER - NOW, 2008-, I DECIDED TO TRY THE OASYS AGAIN, SINCE THE DAILIES WERE MORE EXPENSIVE - AND AFTER THE FIRST DAY MY EYES ARE BEGINNING TO SHOW THE SAME SIGNS OF IRRITATION AND SENSITIVITY TO LIGHT. SO NOW, I'M SWITCHING BACK TO AVOID OASYS LENSES. I'VE NEVER HAD ANY EYE ISSUES UNTIL THE 2007 OASYS INCIDENT. THEY MUST HAVE CHANGED THEIR COMPOSITION OR UPPED THE SILICONE CONTENT OR SOMETHING. THE PRODUCT WAS GREAT AT FIRST, AND IS NOW EXTREMELY PROBLEMATIC. OTHER PEOPLE WITH PROBLEMS CAN BE FOUND. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: PRESCRIPTION CONTACT LENSES FOR -2.25. EVENT ABATED AFTER USE STOPPED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS WITH HYDRACLEAR PLUS OASYS CONTACT LENSES LPL VISTAKON, JOHNSON AND JOHNSON 7 33905 56273 0 B005V6B39R

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other