BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETERNITY X-70

    MDR report key: 2010942 · Received March 4, 2011

    Report

    Report Number
    1119279-2011-00058
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 2, 2011
    Manufacturer
    B+L FOR ADVANCED VISION SYSTEMS
    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

    ROOT CAUSE: ACCORDING TO THE PHYSICIAN, THE ROOT CAUSE OF THE LENS DAMAGE IS RELATED TO A LOADING ERROR AND NOT THE PRODUCT.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY IN THE LEFT EYE WITH ATTEMPTED IMPLANTATION OF THE ETERNITY X-70 INTRAOCULAR LENS. DURING INSERTION USING THE NAVI XJ-70 INJECTOR SYSTEM THE LEADING HAPTIC TORE. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION (APPROXIMATELY 7MM), AND REPLACE THE DAMAGED LENS. SURGEON ALSO NOTED WHEN COMPRESSING THE EYE DURING VITREOUS SURGERY THAT THE ANTERIOR CHAMBER WAS UNSTABLE DUE TO THE CONJUNCTIVAL INCISION ENLARGEMENT.

    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 X-70

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention (B)(4) (NIDEK)| ETERNITY NAVI XJ-70 INSERTER| ACCURUS (ALCON)