BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY TORIC

    MDR report key: 3113747 · Received May 10, 2013

    Report

    Report Number
    9614392-2013-00025
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 14, 2013
    Manufacturer
    COOPERVISION MANUFACTURING, LTD.
    Product Code
    LPM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATION BETWEEN COOPERVISION LENSES AND THE INCIDENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    COOPERVISION WAS MADE AWARE THAT A PATIENT DEVELOPED CORNEAL ULCER IN THE LEFT EYE. PATIENT DIAGNOSED AS EARLY KERATOCONIC BY OPHTHALMOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208967 BIOFINITY TORIC LPM, SOFT CONTACT LENS, EXTENDED WEAR LPM COOPERVISION MANUFACTURING, LTD. 8378001709

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R