BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECT 1 DAY (SOMOFILCON A)

    MDR report key: 6094061 · Received November 10, 2016

    Report

    Report Number
    3009108089-2016-00004
    Event Type
    Injury
    Date Received
    November 10, 2016
    Report Date
    October 16, 2016
    Manufacturer
    COOPERVISION CL KFT
    Product Code
    LPL
    PMA / PMN Number
    K130342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED TO EXPERIENCE AN EYE INFECTION (OS) AND IS NOW ON DROPS TO CONTROL THE INFECTION. IN THE ABSENCE OF MEDICAL INFORMATION, THIS EVENT IS BEING REPORTED IN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743925 SELECT 1 DAY (SOMOFILCON A) SELECT 1 DAY (SOMOFILCON A) LPL COOPERVISION CL KFT H0100145

    Patients

    Seq Age Sex Outcome Treatment
    1 Other