BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS ACCOMMODATING IOL

    MDR report key: 2980466 · Received February 22, 2013

    Report

    Report Number
    2031924-2013-00036
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 24, 2013
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS WAS INSERTED AND REMOVED INTRAOPERATIVELY DUE TO CAPSULAR DAMAGE. THE EVENT ALLEGEDLY OCCURRED UPON IOL INSERTION DUE TO UNUSUAL EJECTION FROM THE INSERTER. THE INCISION WAS ENLARGED TO REMOVE THE LENS, A VITRECTOMY WAS PERFORMED, AND SUTURES WERE USED. REFERENCE MDR #2031924-2013-00037, FOR THE DELIVERY DEVICE USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77272 CRYSTALENS ACCOMMODATING IOL NAA/LENS INTRAOCULAR, ACCOMMODATIVE NAA BAUSCH + LOMB AT50AO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CRYSTALSERT CRYSTALENES DELIVERY SYSTEM