BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROCON RIGID GAS PERMEABLE CONTACT LENS

    MDR report key: 32046 · Received April 17, 1996

    Report

    Report Number
    MW1008883
    Event Type
    Malfunction
    Date Received
    April 17, 1996
    Date of Event
    February 2, 1995
    Report Date
    February 10, 1995
    Manufacturer
    PILKINGTON BARNES-HIND, INC.
    Product Code
    HPX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ALLEGES A CONTACT LENS BROKE IN HER RIGHT EYE. SHE REMOVED IT IN 2 PIECES AND SHE CLAIMS IT CAUSED A CORNEAL ABRASION. SHE CAME IN TO BE EXAMINED APPROX 6 HRS AFTER THE ALLEGED EVENT AND WAS NOT IN PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUOROCON RIGID GAS PERMEABLE CONTACT LENS CONTACT LENS HPX PILKINGTON BARNES-HIND, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other