BEUDAMED
    FDA Adverse Event Other Summary report: N

    ETERNITY

    MDR report key: 1406834 · Received March 25, 2009

    Report

    Report Number
    2020277-2009-00111
    Event Type
    Other
    Date Received
    March 25, 2009
    Date of Event
    October 15, 2008
    Report Date
    March 10, 2009
    Manufacturer
    ADVANCED VISION SCIENCE
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS CONSIDERED THAT INFERIOR PRECISION OF THE INJECTOR CAUSED THIS EVENT, WHERE NO MEDICAL AGENT OR DEVICES USED IN THE OPERATION PLAYED A ROLE.

    Description of Event or Problem · 1

    WHEN TRIED TO INSERT THE IOL WITH THE INJECTOR, IT BECAME HARD TO HANDLE IT WITH A FEELING OF SOMETHING BEING STUCK INSIDE; THEN SUDDENLY, A FEELING OF IT BEING RELEASED, FOLLOWED BY EJECTION OF THE LENS BY A SUDDEN UNCONTROLLED PUSHING FORCE, CAUSING POSTERIOR CAPSULE RUPTURE AS A RESULT. ALTHOUGH POSTERIOR CAPSULE RUPTURE WAS CONFIRMED, WITH NO INTRAOCULAR LENS DISLOCATION OBSERVED, IOL WAS FIXED IN THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETERNITY INTRAOCULAR LENS HQL ADVANCED VISION SCIENCE X-70 1015534

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention