BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED BIO-EYE HA IMPLANT WITH CONFORMER

    MDR report key: 961324 · Received December 7, 2007

    Report

    Report Number
    2027377-2007-00003
    Event Type
    Injury
    Date Received
    December 7, 2007
    Date of Event
    February 17, 2007
    Report Date
    April 19, 2007
    Manufacturer
    INTEGRATED ORBITAL IMPLANTS
    Product Code
    HPZ
    PMA / PMN Number
    K003338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 POLYMER VISIBLE THROUGH THE EXPOSURE IS ANTICIPATED AS THE EXPECTED DISSOLUTION TIME OF THE POLYMER IS 12-15 MONTHS.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT PATIENT RECEIVED BIO-EYE 2006. PATIENT PRESENTED WITH A CENTRAL EXPOSURE POST OPERATIVELY THAT WAS SUCCESSFULLY CLOSED 2 MONTHS POST OP. NOW AT 7 MONTHS POST OP THE PATIENT HAS A 4 MM CENTRAL EXPOSURE. IT IS ALSO NOTED THAT THE ANTERIOR POLYMER IS INTACT. THE PHYSICIAN ASKS FOR SUGGESTIONS REGARDING REPAIR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention