BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALSERT CRYSTALENS DELIVERY SYSTEM

    MDR report key: 3946283 · Received July 9, 2014

    Report

    Report Number
    2031924-2014-00150
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MSS
    PMA / PMN Number
    K082944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 DURING IMPLANTATION THE LENS HAPTIC GOT STUCK IN THE DELIVERY DEVICE. THE INCISION WAS ENLARGED TO REMOVE THE LENS INTRAOPERATIVELY AND ANOTHER LENS WAS IMPLANTED. SUTURES WERE USED TO CLOSE THE WOUND. THE PATIENT'S PROGNOSIS WAS REPORTED AS "EXCELLENT." PLEASE REFERENCE MDR # 201924-2014-00149 FOR THE INTRAOCULAR LENS INVOLVED IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399073 CRYSTALSERT CRYSTALENS DELIVERY SYSTEM MSS/FOLDERS AND INJECTORS, IOL MSS BAUSCH + LOMB CI-28

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other CRYSTALENS ACCOMMODATING IOL