BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED BIO-EYE HA IMPLANT WITH COMFORMER

    MDR report key: 979896 · Received January 15, 2008

    Report

    Report Number
    2027377-2007-00010
    Event Type
    Injury
    Date Received
    January 15, 2008
    Date of Event
    December 18, 2007
    Report Date
    December 18, 2007
    Manufacturer
    INTEGRATED ORBITAL IMPLANTS, INC.
    Product Code
    HPZ
    PMA / PMN Number
    K003338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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 12-18 MONTHS. LESS THAN 15 MONTHS HAD PASSED SINCE IMPLANTATION. DISSOLUTION RATES OF BIORESORBABLE POLYMERS IS DEPENDENT UPON A NUMBER OF CHARACTERISTICS INCLUDING TEMPERATURES 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. DR. RETURNED SAMPLES OF THE PIECES OF COATING SHE REMOVED. THESE WERE EVALUATED AS FOLLOWS: THE EVALUATION CONSISTED OF VISUAL AND PHOTOGRAPHIC EVALUATION AS WELL AS THICKNESS MEASUREMENTS. TO DATE WE HAVE NO VIABLE HYPOTHESIS AS TO THE GENESIS OF THE DISTINCTIVE SHAPES OF THE FRAGMENTS. THE FRAGMENTS PROVIDED MAY HAVE BEEN CUT INTO THEIR CHARACTERISTICS SHAPES BY THE ACTION OF THE PHYSICIAN IN REMOVING THE EXPOSED POLYMER.

    Description of Event or Problem · 1

    DR. REPORTED THAT THE PATIENT HAD BLEEDING AND IRRITATION TO HER EYE PERHAPS CAUSED BY THE COATED BIO-EYE IMPLANT. DR. OPENED UP THE EYE AND FOUND SHARP EDGES OF IMPLANT POKING THROUGH CONJUNCTIVA. SHE CLEANED THE ANTERIOR PART AND "NIPPED AWAY" ABOUT 20-30% OF IMPLANT. SHE TOOK A CULTURE AND CLOSED THE CONJUNCTIVA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED BIO-EYE HA IMPLANT WITH COMFORMER IMPLANT, EYE SPHERE HPZ INTEGRATED ORBITAL IMPLANTS, INC. I0018C 36307

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention