BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRASOFT TORIC (METHAFILCON B)

    MDR report key: 7133865 · Received December 20, 2017

    Report

    Report Number
    1314956-2017-00010
    Event Type
    Injury
    Date Received
    December 20, 2017
    Report Date
    December 20, 2017
    Manufacturer
    COOPERVISION, INC.
    Product Code
    LPL
    PMA / PMN Number
    P850079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT SAMPLE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE ASSOCIATION BETWEEN COOPERVISION LENSES AND THE EVENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING KERATITIS AND NEOVASCULARIZATION IN THE LEFT (OS) EYE WITH BLOOD VESSELS ENCROACHING ON THE PUPIL. GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN ADDITIONAL MEDICAL INFORMATION WITHOUT SUCCESS, ADDITIONAL INFORMATION IS UNKNOWN. THIS EVENT IS BEING REPORTED DUE TO LACK OF MEDICAL INFORMATION, AND UNKNOWN RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914595 HYDRASOFT TORIC (METHAFILCON B) HYDRASOFT TORIC (METHAFILCON B) LPL COOPERVISION, INC. HT0390312H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other