BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EYEQ PREMIUM FOR ASTIGMATISM Q2

    MDR report key: 11677831 · Received April 15, 2021

    Report

    Report Number
    MW5100806
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    April 5, 2021
    Report Date
    April 14, 2021
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SW
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    UNABLE TO READ; MY NAME IS (B)(6), I AM (B)(6), MALE, AND ASIAN. THE PRODUCT IN QUESTION: EYEQ PREMIUM FOR ASTIGMATISM Q2. THIS TYPE OF PRODUCT IS ADVERTISED FOR 30 DAYS OF CONTINUES USE, HOWEVER AFTER 5 DAYS OF USE HAS BECOME UNUSABLE. THE MANUFACTURER IS COOPERVISION INC. I PURCHASED THIS PRODUCT FROM (B)(6) ON THE DATE 30 APRIL. THE PRODUCT HAS CAUSED HEADACHE AND LOSS OF VISUAL FOCUS WHEN USED. THE OUTCOME IS THAT MY WORK IS BEING AFFECTED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568259 EYEQ PREMIUM FOR ASTIGMATISM Q2 LENSES, SOFT CONTACT, DAILY WEAR LPL COOPERVISION CL KFT 101579500120120043
    568260 EYEQ PREMIUM FOR ASTIGMATISM Q2 LENSES, SOFT CONTACT, DAILY WEAR LPL COOPERVISION CL KFT 101579500120120043

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other