BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHOKERATOLOGY LENS

    MDR report key: 241632 · Received September 15, 1999

    Report

    Report Number
    MW1017216
    Event Type
    Other
    Date Received
    September 15, 1999
    Date of Event
    August 15, 1999
    Report Date
    September 15, 1999
    Manufacturer
    UNK
    Product Code
    MUW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    5/98 EYE DR PRESCRIBED ORTHOKERATOLOGY CONTACT LENS (OK LENS). INSTRUCTED PT TO WEAR LENSES EVERY NIGHT AND HE SAID IT WOULD CORRECT THE "SHORT SIGHT" PERMANENTLY. ON 8/15/99, SWELLING OF RIGHT EYE, BURNING AND TINGLING WHEN PT LOOKED AT THE LIGHT. PT WENT TO THE DR'S OFFICE AND HE SAID SWELLING WAS CAUSED BY A VIRAL INFECTION. HE ADVISED PT TO ENCOURAGE FLUID INTAKE AND THAT SHE COULD CONTINUE TO WEAR OK LENS AT NIGHT. PT STOPPED WEARING OK LENS ON RIGHT EYE, BUT CONTINUED TO WEAR OK LENS ON LEFT EYE. ON 8/29, SAME CONDITION HAPPENED ON THE LEFT EYE. NOW THE SHORT SIGHT RETURNS WHEN NOT WEARING THE OK LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOKERATOLOGY LENS ORTHOKERATOLOGY LENS MUW UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other