BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCLEAR CONTACT LENS

    MDR report key: 8912134 · Received August 19, 2019

    Report

    Report Number
    MW5089170
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    August 14, 2019
    Report Date
    August 15, 2019
    Manufacturer
    COOPERVISION, INC.
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I OPENED A SEALED CONTACT LENS (PROCLEAR FROM COOPERVISION) AND FOUND IT WAS DRY. THE PLASTIC PACKAGING HAS AN OBVIOUS DEFECT THAT ALLOWED FLUID TO EITHER LEAK OR EVAPORATE FROM PACKAGING (CARDBOARD BOX) EXP (17) 09/30/2022, LOT (10): 15270000128022. BARCODE 7 07482 02615 2, MADE IN UK. THINKING BACK TO USE OF PREVIOUS CONTACTS FROM THIS BOX, IT SEEMS POSSIBLE THAT PREVIOUS CONTACTS APPEARED TO BE SEALED NORMALLY BUT HAD LESS THAN NORMAL FLUID. QUESTION FOR THE AGENCY, IS THERE A POSSIBILITY OF BACTERIAL CONTAMINATION OF UNSEALED PRODUCT? FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698689 PROCLEAR CONTACT LENS LENSES, SOFT CONTACT, DAILY WEAR LPL COOPERVISION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1