BEUDAMED
    FDA Adverse Event Other Summary report: N

    RE-NU

    MDR report key: 702624 · Received April 12, 2006

    Report

    Report Number
    MW1038521
    Event Type
    Other
    Date Received
    April 12, 2006
    Date of Event
    October 5, 2005
    Report Date
    April 12, 2006
    Manufacturer
    *
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD BEEN HAVING REDNESS -BAD-, TEARS, SOMETIMES ITCHY WELL, IT FELT LIKE SOMETHING WAS SCRATCHING MY EYE, AND SOMETIMES BLURRY VISION WHILE WEARING MY CONTACTS. AFTER TAKING THEM OUT FOR ABOUT A WEEK MY EYES WOULD ALMOST BE NORMAL AGAIN. I WOULD PUT MY CONTACTS BACK IN -A NEW PAIR- AND AFTER A FEW DAYS THEY WOULD START TURNING RED AGAIN AND BOTHER ME. AFTER ABOUT A MONTH OF THIS I WENT TO MY EYE DR AND HE SAID I HAD AN INFECTION AND THE INSIDE OF MY EYE WAS ENLARGED AND HE DIDN'T KNOW WHY. HE HAD ME WEAR GLASSES FOR 4 WEEKS AND GAVE ME SOME EYE DROPS TO HELP WITH THE ITCHING/SCRATCHY AND REDNESS. I WENT BACK APROX 4 WEEKS LATER, AND WE CHANGED MY SOLUTION FROM RE-NU TO CLEAR CARE. THE PROBLEM DIDN'T COME BACK ONCE I CHANGED THE SOLUTION. I HAVE NOT GONE BACK TO RE-NU AS I DON'T WANT IT TO HAPPEN AGAIN. I WAS JUST INFORMED OF THIS RECALL WITH RE-NU AND SOFT CONTACTS. I WEAR THE DISPOSABLE ONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RE-NU * LPN * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other