BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILIES TOTAL 1 (90 PACK)

    MDR report key: 7573016 · Received June 5, 2018

    Report

    Report Number
    MW5077657
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    May 16, 2018
    Report Date
    June 4, 2018
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THESE ARE DAILY CONTACTS - I HAVE PURCHASED 8 BOXES OF 90 AND EXPERIENCED A VERY HIGH DEFECT RATE. OVER 10% I PUT ONE IN MY EYE AND I CAN'T SEE CLEARLY. I THROW IT OUT, PUT A NEW ONE IN AND I SEE FINE. I CONTACTED THE COMPANY DIRECTLY OVER A WEEK AGO AND HAVE NOT HEARD BACK. I HAVE SOME LEFT FROM THIS BATCH. I WILL TRY TO SAVE THE NEXT DEFECTIVE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411295 DAILIES TOTAL 1 (90 PACK) LENSES, SOFT CONTACT, DAILY WEAR LPL ALCON LABORATORIES, INC. DAILIES TOTAL 1 (90 PACK) A5020292

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR