BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEWVUE

    MDR report key: 20198 · Received March 9, 1995

    Report

    Report Number
    MW1005387
    Event Type
    Injury
    Date Received
    March 9, 1995
    Date of Event
    February 17, 1995
    Report Date
    February 27, 1995
    Manufacturer
    CIBA VISION CORP.
    Product Code
    LPM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED WITH RED RIGHT EYE WITH MUCOID DISCHARGE. BULBAR INJECTION OD WAS GRADE 2. PAPILLARY AND FOLLICULAR RESPONSE ON PALPEBRAL CONJUNCTIVA OD. AS THE CONJUNCTIVITIS MAY OR MAY NOT BE CAUSED OR EXACERBATED BY THE CONTACTS, THE ADVERSE EVENT HERE IS PROMINENT NEOVASCULARIZATION OF EACH CORNEA SUPERIORLY AND INFERIORLY OF UP TO 2 MM. PT ASSURES DR HE FOLLOWS THE EW PROTOCOL. THE PT HAS NO GLASSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWVUE CONTACT LENS LPM CIBA VISION CORP. -3.0 14 365470

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention