BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER TOPIC CONTACT LENSES

    MDR report key: 11760703 · Received April 30, 2021

    Report

    Report Number
    MW5101127
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 29, 2021
    Report Date
    April 29, 2021
    Manufacturer
    COOPERVISION INC.
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED CONTACT LENSES FROM (B)(6) IN (B)(6) 2020. SINCE THEN, OUT OF TOTAL 12 LENSES, 6 LENSES HAVE TORN. THE TORN LENSES HAVE TORN IN MY EYE. I WAS ABLE TO REMOVE 3 OUT OF 6 WITH SOME EFFORT; BUT 3 OUT OF 3 WITH DIFFICULTY. IN FACT, ONE STAYED IN MY EYE FOR OVER 3 DAYS UNTIL I COULD REMOVE IT. I FOLLOWED UP WITH MY EYE DOCTOR TO CHECK MY EYE AFTER THIS. AT THIS TIME I CAN DETECT NO PROBLEM. BOTH RIGHT AND LEFT LENSES HAVE TORN. I CALLED (B)(6) AND REPORTED THIS PROBLEM. I ASKED THEM TO REPORT THIS AS WELL. I HAVE BEEN ORDERING CONTACTS FROM THEM FOR OVER 10 YEARS. HAD A SIMILAR PROBLEM OVER 5 YEARS AGO. NO PROBLEM UNTIL THIS RECENT SHIPMENT OF CONTACTS ORDERED IN (B)(6) 2020. I HAVE A COPY OF THE PRODUCT CODE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647319 PROWLER TOPIC CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL COOPERVISION INC. (10)CV7972021
    647320 PROWLER TOPIC CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL COOPERVISION INC.
    647321 PROWLER TOPIC CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL COOPERVISION INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR