BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALSERT CRYSTALENS DELIVERY SYSTEM

    MDR report key: 3123621 · Received May 17, 2013

    Report

    Report Number
    2031924-2013-00095
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MSS
    PMA / PMN Number
    K082944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS RETURNED TO BAUSCH + LOMB FOR EVALUATION. 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 INTRAOPERATIVELY REMOVED FROM THE PATIENT'S EYE DUE TO DIFFICULTY POSITIONING THE LENS PROPERLY. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND SUTURES WERE USED TO CLOSE THE WOUND. A DIFFERENT LENS MODEL WAS IMPLANTED SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. PLEASE REFERENCE MDR# 2031924-2013-00094 FOR THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219364 CRYSTALSERT CRYSTALENS DELIVERY SYSTEM MSS / FOLDERS AND INJECTORS, IOL MSS BAUSCH + LOMB CI-28B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CRYSTALENS ACCOMMODATING IOL