BEUDAMED
    FDA Adverse Event Other Summary report: N

    ETERNITY

    MDR report key: 1406839 · Received March 25, 2009

    Report

    Report Number
    2020277-2009-00110
    Event Type
    Other
    Date Received
    March 25, 2009
    Date of Event
    December 8, 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 THIS EVENT HAS NOTHING TO DO WITH ANY MEDICAL DEVICE OR MEDICAL AGENT USED IN THE SURGERY. IT WAS INFERIOR PRECISION OF THE INJECTOR THAT PREVENTED THE INJECTOR FROM FUNCTIONING SMOOTHLY, THEREBY MAKING THE LOOP POP OUT UNCONTROLLABLY.

    Description of Event or Problem · 1

    WHEN TRIED TO EJECT THE IOL WITH THE INJECTOR, THE TUCKED PRECEDING LOOP (HAPTIC) POPPED OUT FROM THE TIP, CAUSING POSTERIOR CAPSULE RUPTURE. AS THE POSTERIOR CAPSULE RUPTURE WAS CONFIRMED, THE PRECEDING LOOP WAS SUTURED TO THE CILIARY SULCUS WHILE PLACING OPTICS TEMPORARILY ON THE BAG, AND MOVED THE TRAILING LOOP OUT OF THE EYE. AFTER CONFIRMING THE COMPLETE CCC WHEN EXAMINED THE STATE OF THE RUPTURE, BOTH LOOPS (HAPTICS) WERE SUTURED TO THE CILIARY SULCUS FIRST, THEN THE OPTIC WAS TUCKED INTO THE POSTERIOR CAPSULE THROUGH CCC TO FIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETERNITY INTRAOCULAR LENS HQL ADVANCED VISION SCIENCE X-70 1014823

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention