BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETERNITY X-70

    MDR report key: 2201864 · Received August 5, 2011

    Report

    Report Number
    2031924-2011-00129
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 7, 2011
    Manufacturer
    B+L FOR ADVANCED VISION SYSTEMS (AVS)
    Product Code
    HQL
    PMA / PMN Number
    P080021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN SUSPECTS THAT THE PT DEVELOPED INFECTIOUS ENDOPHALMITIS, BASED ON THE FACT THAT CELLS ADHERED TO THE LENS SURFACE. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT AN X-70 INTRAOCULAR LENS WAS IMPLANTED IN THE LEFT EYE OF A PT WITH UVEITIS DURING SIMULTANEOUS VITREOUS SURGERY. IT WAS REPORTED THAT THE PT HAD INFECTIOUS ENDOPHTHALMITIS. THE LENS WAS REMOVED AND THE PT IS CURRENTLY APHAKIC. THE PT IS IN THE HOSPITAL FOR F/U.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETERNITY X-70 HYDROPHOBIC ACRYLIC ONE PIECE IOL HQL B+L FOR ADVANCED VISION SYSTEMS (AVS) X-70 1032748-42

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention