BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITRASERT

    MDR report key: 32239 · Received April 24, 1996

    Report

    Report Number
    MW1008945
    Event Type
    Malfunction
    Date Received
    April 24, 1996
    Date of Event
    April 18, 1996
    Report Date
    April 23, 1996
    Manufacturer
    CHIRON VISION CORP.
    Product Code
    LZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THREE OF 6 UNITS (IMPLANTS) APPEARED TO BE DEFECTIVE AT THE TIME OF REMOVAL FROM THE STERILE PACKAGING PRIOR TO INSERTION INTO THE PT'S EYE. PORTIONS OF THE IMPLANTS SEEMED TO ADHERE TO THE PACKAGING. OTHER DEFECTS OR LACK OF UNIFORMITY OF THE IMPLANT SURFACE WERE VISUALIZED UNDER THE SURGICAL MICROSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITRASERT VISCOELASTIC SURGICALAID LZP CHIRON VISION CORP. QR000003

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO