BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-EYE

    MDR report key: 1907132 · Received November 10, 2010

    Report

    Report Number
    2027377-2010-00002
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 16, 2010
    Manufacturer
    INTEGRATED ORBITAL IMPLANTS
    Product Code
    HPZ
    PMA / PMN Number
    K982562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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%. THE DISTRIBUTOR REPORTED TO THE MANUFACTURER THAT A SURGEON IN (B)(4) CONDUCTING A CLINICAL INVESTIGATION WITH THE COATED BIO-EYE HAD EXPOSURES IN PTS IMPLANTED WITH COATED BIO-EYE. SURGEON HAS BEEN UNRESPONSIVE TO FOLLOW UP CONTACTS TO PROVIDED ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED EXPOSURES IN PTS WHO HAD RECEIVED THE COATED BIO-EYE AS PART OF A CLINICAL INVESTIGATION IN EUROPE.

    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 UNK Required Intervention