BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-EYE

    MDR report key: 261318 · Received February 5, 2000

    Report

    Report Number
    2027377-2000-00001
    Event Type
    Injury
    Date Received
    February 5, 2000
    Report Date
    February 5, 2000
    Manufacturer
    INTEGRATED ORBITAL IMPLANTS, INC.
    Product Code
    HPZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THAT AN IMPLANT THAT HAD BEEN PLACED IN 1995 BECAME EXPOSED IN 1999. PT SOUGHT CARE AND EVENTUALLY WAS ADVISED BY A DR THAT THE CONDITION MIGHT BE RESOLVED BY REMOVAL OF THE IMPLANT. THE IMPLANT WAS REMOVED AND REPLACED, ACCORDING TO THE PT, WITH AN ACRYLIC IMPLANT, REPORTEDLY IN 1999. FOLLOW-UP WITH THE SURGEON CONFIRMED THE REPLACEMENT. SURGEON STATES THERE WAS NO INDICATION ON DR'S PART THAT THERE WAS ANY PROBLEM FROM THE IMPLANT MATERIAL ITSELF. DR NOTED THAT ANY IMPLANT MATERIAL CAN HAVE EXPOSURE AND BE THE CAUSE FOR REMOVAL. DR REPORTED THAT A BACTERIAL CULTURE WAS TAKEN AND WAS NEGATIVE. DR REPORTED THAT PT HAS DONE WELL WITH REMOVAL OF THE IMPLANT AND PLACEMENT OF A SILICONE SPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-EYE OCULAR IMPLANT HPZ INTEGRATED ORBITAL IMPLANTS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention