BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 DELIVERY SYSTEM

    MDR report key: 1971569 · Received January 24, 2011

    Report

    Report Number
    1119279-2011-00019
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE AKREOS AO INTRAOCULAR LENS IN THE LEFT EYE USING THE VISCOJECT 1.8 DELIVERY DEVICE. INTRAOPERATIVELY, THE SURGEON FOUND THE IOL WOULD NOT INSERT PROPERLY. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION AND REMOVE THE LENS. A SECOND AKREOS AO INTRAOCULAR LENS WAS IMPLANTED SUCCESSFULLY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISCOJECT 1.8 DELIVERY SYSTEM IOL INSERTER/INJECTOR MSS BAUSCH & LOMB LP604350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AKREOS AO INTRAOCULAR LENS (B&L)