BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYTALSERT CRYSTALENS DELIVERY SYSTEM

    MDR report key: 2598956 · Received May 30, 2012

    Report

    Report Number
    2031924-2012-00045
    Event Type
    Injury
    Date Received
    May 30, 2012
    Date of Event
    April 26, 2012
    Report Date
    April 30, 2012
    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 REQUESTED, BUT WAS NOT RETURNED TO BAUSCH AND LOMB FOR EVAL. 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 TWO AT50AO CRYSTALENS IOL'S WERE INSERTED AND REMOVED INTRAOPERATIVELY DUE TO LENS TEARS. TWO CI-28 DELIVERY DEVICES WERE USED IN THE CASE, ONE FOR EACH LENS. THE INCISION WAS NOT ENLARGED, BUT SUTURES WERE USED TO CLOSE THE WOUND. ANOTHER LENS OF SAME MODEL WAS IMPLANTED SUCCESSFULLY, AND THERE WERE NO REPORTED POSTOPERATIVE SEQUELAE. ACCORDING TO THE SURGEON THE MOST LIKELY CAUSE OF THE EVENT WAS LOADING ERROR. THIS REPORT IS FOR THE FIRST DELIVERY DEVICE. PLEASE REFERENCE MDR#: 2031924-2012-00043 FOR THE FIRST IOL, 2031924-2012-00044 FOR THE SECOND IOL AND 2031924-2012-00046 FOR THE SECOND DELIVERY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYTALSERT CRYSTALENS DELIVERY SYSTEM IOL INSERTER/INJECTOR MSS BAUSCH + LOMB CI-28B

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other CRYSTALENS INTRAOCULAR LENS (B+L)