BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROCON

    MDR report key: 12249 · Received March 24, 1994

    Report

    Report Number
    MW1001206
    Event Type
    Malfunction
    Date Received
    March 24, 1994
    Report Date
    March 22, 1994
    Manufacturer
    PILKINGTON BARNES-HIND, INC.
    Product Code
    HPX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRODUCT WAS NEVER DISPENSED TO THE PT. VERIFICATION OF BASE CURVE OF LENS RESULTED IN RPTR'S REJECTION OF THE PRODUCT. BASE CURVE IS LABELED 8.15. IT VERIFIES AS 8.20, WELL BEYOND TOLERANCE. CORNEAL HEALTH COULD HAVE BEEN COMPROMISED BY THIS POOR QUALITY CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUOROCON RIGID GAS PERMEABLE CONTACT LENS HPX PILKINGTON BARNES-HIND, INC. 8.15/9.5 DIAM HABJR

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other