BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROXYAPATITE BIO-EYE

    MDR report key: 217801 · Received April 5, 1999

    Report

    Report Number
    217801
    Event Type
    Malfunction
    Date Received
    April 5, 1999
    Date of Event
    March 16, 1999
    Report Date
    April 5, 1999
    Manufacturer
    INTEGRATED ORBITAL IMPLANTS
    Product Code
    HPZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN FOR ENUCLEATION OF THE RIGHT EYE ON 3/16/99. PHYSICIAN REQUESTED 18MM IMPLANT, ONE WAS OPENED. PHYSICIAN MEASURED IT AND FOUND TO BE 16MM. THEN A 20MM WAS OPENED AND IT MEASURED TO BE A 18MM (SERIAL #49201, LOT 605407). THIS IMPLANT WAS USED FOR THIS PT. THE ACTUAL SIZE OF THE IMPLANT DID NOT CORRELATE WITH PACKAGING INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROXYAPATITE BIO-EYE Implant OCULAR IMPLANT HPZ INTEGRATED ORBITAL IMPLANTS * 503412
    2 HYDROXYAPATITE BIO-EYE Implant OCULAR IMPLANT HPZ INTEGRATED ORBITAL IMPLANTS * 605407

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR PACKAGING MATERIAL SAVED.