BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-EYE

    MDR report key: 974749 · Received January 2, 2008

    Report

    Report Number
    2027377-2007-00005
    Event Type
    Injury
    Date Received
    January 2, 2008
    Date of Event
    December 21, 2007
    Report Date
    December 13, 2007
    Manufacturer
    INTEGRATED ORBITAL IMPLANTS, INC.
    Product Code
    HPZ
    PMA / PMN Number
    K982562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    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%. DISCUSSION OF THESE CASES WITH THE REPORTING PHYSICIAN SUGGESTS A CORRELATION WITH CHANGES IN THE CLINIC'S WRAPPING PRACTICES. IT IS UNKNOWN WHETHER THERE IS A CAUSAL RELATIONSHIP. WE ARE ANTICIPATING THE RETURN OF THE EXPLANTED DEVICES FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    PHYSICIAN'S OFFICE REPORTED THAT THE DOCTOR IMPLANTED A 20MM STERILE IMPLANT. THE PT NOW HAS AN "EXPOSED" IMPLANT. PT RETURNED FOR SURGERY TO EXPLANT DEVICE IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-EYE IMPLANT, EYE SPHERE HPZ INTEGRATED ORBITAL IMPLANTS, INC. I00020S 976115C

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention