BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 1940307 · Received December 17, 2010

    Report

    Report Number
    1119279-2010-00122
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE SILICONE (B)(4) INTRAOCULAR LENS (IOL) USING THE EZ-28 DELIVERY DEVICE SYSTEM. INTRAOPERATIVELY, THE SURGEON WAS UNABLE TO PROPERLY POSITION THE IOL IN THE CAPSULAR BAG. THE IOL WAS REMOVED, A VITRECTOMY WAS PERFORMED AND AN ANTERIOR CHAMBER IOL WAS IMPLANTED SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. REFERENCE MDR #1119279-2010-000121.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ-28 DELIVERY SYSTEM IOL INSERTER/INJECTOR MSS BAUSCH & LOMB EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SILICONE ADVANCED OPTIC LENS (B+L)