BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCLEAR ULTRAVUE TORIC CONTACT LENS

    MDR report key: 6080965 · Received November 2, 2016

    Report

    Report Number
    MW5065830
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 2, 2016
    Manufacturer
    COOPERVISION, INC.
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONTACT LENSES TEARING WHILE WEARING THEM FOR NO REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725806 PROCLEAR ULTRAVUE TORIC CONTACT LENS HYDROPHILIC SOFT CONTACT LENS LPL COOPERVISION, INC. 707482079516 100625000270160720

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other