BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY MULTIFOCAL COMFILCON A

    MDR report key: 2922504 · Received January 18, 2013

    Report

    Report Number
    9614392-2013-00005
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    January 4, 2013
    Manufacturer
    COOPERVISION MANUFACTURING LIMITED
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    COOPERVISION WAS MADE AWARE OF A COMPLAINT. IT IS REPORTED THAT THE PATIENT WENT FOR A SCHEDULED ANNUAL CHECK-UP AND THAT THE PATIENT EXPERIENCED A FOREIGN BODY FEELING DURING THE LAST MONTH THAT ESCALATED IN THE LEFT EYE THE LAST FEW DAYS. THE PATIENT SLEEPS WITH THE LENSES BUT REMOVES THEM TWICE A MONTH TO PROPERLY CLEAN. NO PAIN, PHOTOPHOBIA ARE REPORTED. DURING THE EXAM UNDER MICROSCOPE, A WOUND (SCAR) MEASURING 1MM IS DISCOVERED ON LEFT CORNEA AT 1 O'CLOCK. ALSO REPORTED IS AN INJECTED LIMBUS THAT IS COLORED WHEN USING FLUORESCEIN. NO LOT INFORMATION WAS PROVIDED AND THE LENSES WERE DISCARDED. THE PATIENT WAS PRESCRIBED LENS REST, AND WILL BE EXAMINED AGAIN IN 24HRS. PATIENT ADVISED TO SEEK ACUTE MEDICAL CARE IF IT GETS PAINFUL OR VISION IS DECREASED. ATTEMPTS TO FOLLOW UP WERE MADE WITH NO REPLY TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27227 BIOFINITY MULTIFOCAL COMFILCON A LPM, SOFT CONTACT LENS, EXTENDED WEAR LPM COOPERVISION MANUFACTURING LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability