BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFLEX THREE-PIECE FOLDABLE LENS

    MDR report key: 3241063 · Received April 12, 2006

    Report

    Report Number
    1920664-2007-00445
    Event Type
    Injury
    Date Received
    April 12, 2006
    Date of Event
    March 14, 2007
    Report Date
    March 14, 2007
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    WHEN THIS LENS WAS BEING PLACED INTO THE EYE, IT BROKE THROUGH THE CAPSULE. THE LENS WAS REMOVED, A VITRECTOMY WAS PERFORMED AND AN ANTERIOR LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFLEX THREE-PIECE FOLDABLE LENS INTRAOCULAR LENS HQL BAUSCH & LOMB, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention