BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALSERT CRYSTALENS DELIVERY SYSTEM

    MDR report key: 2010960 · Received March 4, 2011

    Report

    Report Number
    2031924-2011-00057
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MSS
    PMA / PMN Number
    K082944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DELIVERY DEVICE WAS NOT PROVIDED, AND THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, AN INVESTIGATION COULD NOT BE CONDUCTED.

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF A CRYSTALENS INTRAOCULAR LENS USING A CI-28 DELIVERY DEVICE. INTRAOPERATIVELY, THE SURGEON NOTICED THAT THE TRAILING HAPTIC WAS BROKEN. SUBSEQUENTLY, THE ORIGINAL INCISION WAS SLIGHTLY ENLARGED TO REMOVE THE LENS. A SECOND LENS OF THE SAME MODEL WAS IMPLANTED. REFERENCE MANUFACTURE REPORT #: 2031924-2011-00056.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALSERT CRYSTALENS DELIVERY SYSTEM IOL INSERTER/INJECTOR MSS BAUSCH + LOMB CI-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CRYSTALENS INTRAOCULAR LENS (B+L)