BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESIO

    MDR report key: 7568726 · Received June 4, 2018

    Report

    Report Number
    MW5077620
    Event Type
    Injury
    Date Received
    June 4, 2018
    Date of Event
    March 31, 2018
    Report Date
    June 4, 2018
    Manufacturer
    QUALIMED SRL
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER PURCHASED COLOR CONTACT LENSES ONLINE FOR COSMETIC USE WITHOUT A REQUIRED PRESCRIPTION. SHE REPORTS EYE IRRITATION, DRYNESS, SORENESS AND REDNESS IMMEDIATELY AFTER USE. ABOUT 4 MONTHS LATER OF INTERMITTENT USE SHE HAS AN EYE INFECTION AND INFLAMMATION IN BOTH EYES. SHE HAS STOPPED USING THE CONTACTS AND IS NOW ON ANTIBIOTICS FOR THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408400 DESIO LENSES, SOFT CONTACT, DAILY WEAR LPL QUALIMED SRL

    Patients

    Seq Age Sex Outcome Treatment
    1