BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-EYE

    MDR report key: 1546841 · Received November 25, 2009

    Report

    Report Number
    2027377-2009-00002
    Event Type
    Injury
    Date Received
    November 25, 2009
    Date of Event
    October 15, 2009
    Report Date
    October 30, 2009
    Manufacturer
    INTEGRATED ORBITAL IMPLANTS
    Product Code
    HPZ
    PMA / PMN Number
    K982562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EXPOSURES ARE AN ANTICIPATED POSSIBLE COMPLICATION WITH THIS TYPE OF SURGERY. A REVIEW OF THE LITERATURE FINDS EXPOSURE RATES RANGING FROM 2.5% TO 21.6%. EXPOSURES DO NOT REQUIRE THE REMOVAL OF THE IMPLANT, SO THE IMPLANT WAS NOT EXPLANTED; SO IT COULD BE RETURNED FOR AN INVESTIGATION. PT'S MOTHER COMPLAINED TO MFR TO SEE WHAT ELSE COULD BE DONE. PT'S MOTHER DID NOT WANT THE DOCTOR CONTACTED, SO WE DON'T HAVE ANY WAY TO GET MORE COMPLETE INFO REGARDING EXACT PRODUCT MODEL, SIZE, LOT OR SERIAL NUMBER OF THE IMPLANT.

    Description of Event or Problem · 1

    PT'S MOTHER REPORTED THAT HER SON HAD RECEIVED AN ORBITAL IMPLANT IN 2005. THIS SUMMER THE OCULARIST NOTICED THAT THE IMPLANT WAS EXPOSED. PT HAD SURGERY IN 2009 TO TRY TO CORRECT THE EXPOSURE. PT AND DOCTOR UNHAPPY WITH THE RESULTS OF THE SURGERY TO CORRECT THE EXPOSURE. DEVICE WAS NOT EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention