BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1991106 · Received February 11, 2011

    Report

    Report Number
    2031924-2011-00038
    Event Type
    Injury
    Date Received
    February 11, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE SURGEON, THERE WAS NO ISSUE WITH THE INTRAOCULAR LENS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE CRYSTALENS INTRAOCULAR LENS. ACCORDING TO THE INFORMATION RECEIVED, THE SURGEON COULD NOT POSITION THE LENS CORRECTLY DURING IMPLANTATION DUE TO A TEAR IN THE CAPSULAR BAG. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION AND REMOVE THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH + LOMB AT50AO 019125

    Patients

    Seq Age Sex Outcome Treatment
    1 Other