BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALSERT

    MDR report key: 2010940 · Received March 4, 2011

    Report

    Report Number
    2031924-2011-00055
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    December 7, 2010
    Report Date
    February 4, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MSS
    PMA / PMN Number
    K082944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF A CRYSTALENS IOL USING A CRYSTALSERT DELIVERY DEVICE. ACCORDING TO THE INFORMATION RECEIVED, THE LENS WAS IMPLANTED AND REMOVED IMMEDIATELY DUE TO A CAPSULAR TEAR. NO FURTHER INFORMATION COULD BE OBTAINED FROM THE CUSTOMER. REFERENCE MDR #: 2031924-2011-00054.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other CRYSTALENS AO INTRAOCULAR LENS (B+L)