BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-EYE HA IMPLANT WITH CONFORMER

    MDR report key: 961320 · Received December 7, 2007

    Report

    Report Number
    2027377-2007-00002
    Event Type
    Injury
    Date Received
    December 7, 2007
    Date of Event
    April 16, 2007
    Report Date
    April 17, 2007
    Manufacturer
    INTEGRATED ORBITAL IMPLANTS
    Product Code
    HPZ
    PMA / PMN Number
    K982562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    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. IN THIS INSTANCE, THE EXPOSURE IS REPORTED TO HAVE BEEN SLOWLY HEALING ON ITS OWN; HOWEVER, PT ELECTED TO HAVE IT SURGICALLY CLOSED. DISCHARGE IS AN ANTICIPATED COMPLICATION OF ORBITAL IMPLANT SURGERY AND IN PARTICULAR MOTILITY PEG SURGERY. IT IS GENERALLY TREATED CONSERVATIVELY WITH THE USE OF TOPICAL ANTI-INFLAMMATORIES AND ANTIBIOTICS. THERE IS NO ANTICIPATED LONG TERM DEGRADATION EXPECTED WITH THE USE OF MOTILITY PEGS.

    Description of Event or Problem · 1

    PT REPORTED THAT PROSTHETIC EYE FEELS LIKE IT IS COVERED WITH STICKY GLUE IN THE MORNING AND THAT THE IMPLANT IS PROTRUDING ABOVE THE PEG "AS IF THE IMPLANT IS GROWING OUT OF MY SOCKET." PT DISCUSSED CONDITION WITH DR WHO SUGGESTED THAT THE EXPOSURE COULD BE WATCHED AS IT WAS SLOWLY GROWING SMALLER AND MIGHT HEAL ON ITS OWN. PT ELECTED TO HAVE SURGERY TO CLOSE EXPOSURE AND REDUCE DISCHARGE. PT REPORTS GOOD RESULTS 5 WEEKS POST SURGERY, THAT CONFORMER BEING USED AND THAT NEW ARTIFICIAL EYE NOT YET MADE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention TOBRADEX FOR INFLAMMATION| UNK FOR EXPOSURE