BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALSERT CRYSTALENS DELIVERY SYSTEM

    MDR report key: 2980444 · Received February 22, 2013

    Report

    Report Number
    2031924-2013-00037
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 24, 2013
    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

    Additional Manufacturer Narrative · 1

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

    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 #2031924-2013-00036 FOR THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77531 CRYSTALSERT CRYSTALENS DELIVERY SYSTEM MSS/FOLDERS AND INJECTORS, IOL MSS BAUSCH + LOMB CI-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CRYSTALENS ACCOMODATING IOL