BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROPHOBIC ACRYLIC ONE PIECE IOL

    MDR report key: 1760588 · Received July 14, 2010

    Report

    Report Number
    1920664-2010-00190
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 18, 2010
    Manufacturer
    ADVANCED VISION SCIENCE, INC
    Product Code
    HQL
    PMA / PMN Number
    P080021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    AFTER IMPLANTING THE LENS, THE SURGEON NOTICED THAT THE TRAILING HAPTIC WAS MISSING. HE ENLARGED THE INCISION TO REMOVE AND REPLACE THE LENS WITH NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROPHOBIC ACRYLIC ONE PIECE IOL ETERNITY NX-60 HQL ADVANCED VISION SCIENCE, INC X-70

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention XJ-60 INSERTER