BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMEDICS 55 -5.50

    MDR report key: 3193499 · Received June 20, 2013

    Report

    Report Number
    MW5030673
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 20, 2013
    Manufacturer
    COOPERVISION
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHEN OPENING MY BIOMEDIC 55 DISPOSABLE CONTACTS BY OCULAR SCIENCES I NOTICED A SMALL FOREIGN SUBSTANCE IN THE SALINE. IT WAS ABOUT 1MMX3MM WAS CLEAR AND LOOKED LIKE A PIECE OF PLASTIC OR GLASS. INFO ON PACKET: ASPHERIC CONTACT LENS 55UV, D-5.50, BC8.60 LOT455354714322, DIA 14.20, EXP 2018/09. I PURCHASED THE CONTACTS AT MY EYE DOCTOR'S OFFICE. I CONTACTED COOPERVISION BUT NO ONE RESPONDED TO MY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281481 BIOMEDICS 55 -5.50 DISPOSABLE CONTACTS LPL COOPERVISION 455354714322

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR