BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED BIO-EYE HA IMPLANT WITH CONFORMER

    MDR report key: 961321 · Received December 7, 2007

    Report

    Report Number
    2027377-2007-00001
    Event Type
    Injury
    Date Received
    December 7, 2007
    Date of Event
    February 17, 2007
    Report Date
    February 17, 2007
    Manufacturer
    INTEGRATED ORBITAL IMPLANTS
    Product Code
    HPZ
    PMA / PMN Number
    K003338
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPOSURE IS AN ANTICIPATED COMPLICATION OF ORBITAL IMPLANT SURGERY. IT IS GENERALLY TREATED CONSERVATIVELY AND IS SURGICALLY CLOSED ONLY IN THE CASE OF LARGE EXPOSURES OR IF THE WOUND DOES NOT SPONTANEOUSLY CLOSE WITHIN A REASONABLE TIME PERIOD. THE ANTERIOR SHELL OF THE COATED BIO-EYE IMPLANT IS DESIGNED TO RESORB IN 12-15 MONTHS. IT'S PRESENCE VISIBLE THROUGH THE EXPOSURE AT 24 MONTHS IS THEREFORE REPORTED AS A MALFUNCTION. DISSOLUTION RATES OF BIORESORBABLE POLYMERS IS DEPENDANT UPON A NUMBER OF CHARACTERISTICS INCLUDING TEMPERATURE AND HYDRATION, AND IS ANTICIPATED TO VARY BASED UPON THE INDIVIDUAL PATIENT'S PHYSIOLOGY. IN THE EVENT THAT THE EXPOSURE WAS OF PROLONGED DURATION THE POLYMER WOULD NOT BE HYDRATED, AND THEREFORE NOT SUBJECT TO THE DESIGNED RATE OF DEGRADATION.

    Description of Event or Problem · 1

    DR. REPORTED THAT PATIENT WAS IMPLANTED WITH COATED BIO-EYE TWO YEARS EARLIER AND THAT PATIENT WAS CURRENTLY EXPERIENCING AN EXPOSURE OF THE IMPLANT AND ITS ANTERIOR SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED BIO-EYE HA IMPLANT WITH CONFORMER IMPLANT, EYE SPHERE HPZ INTEGRATED ORBITAL IMPLANTS

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention