BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCLEAR -3.25

    MDR report key: 660635 · Received December 30, 2005

    Report

    Report Number
    MW1037340
    Event Type
    Malfunction
    Date Received
    December 30, 2005
    Date of Event
    October 19, 2005
    Report Date
    December 30, 2005
    Manufacturer
    COOPERVISION
    Product Code
    LPM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAD A CONTACT LENS COME APART WHILE IN EYE. THIS HAPPENED THREE TIMES, 3 DIFFERENT LENSES, BEFORE PT DECIDED TO REPORT THIS EVENT TO EYE CARE DOCTOR. HAVING TO REMOVE SMALL PIECES OF THE LENS WAS VERY HARD. WHEN IT CAME APART, THE PT FEELING WAS LIKE SOMEONE WAS STABBING PT IN THE EYE. PT WAS TOLD BY THE DOCTOR THAT THEY WERE HER SECOND PT TO REPORT THIS PROBLEM USING THE SAME BRAND OF CONTACT LENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCLEAR -3.25 * LPM COOPERVISION * 200517678F

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other