BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALSERT CRYSTALENS DELIVERY SYSTEM

    MDR report key: 1961012 · Received January 11, 2011

    Report

    Report Number
    2031924-2011-00020
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    November 17, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K082944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE CRYSTALENS INTRAOCULAR LENS. DURING LENS IMPLANTATION, THE HAPTIC TWISTED. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION AND REMOVE THE LENS. ANOTHER INTRAOCULAR LENS WAS IMPLANTED SUCCESSFULLY. REFERENCE MDR # 2031924-2011-00015.

    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 IOL (B+L)