BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALSERT CRYSTALENS DELIVERY SYSTEM

    MDR report key: 2922374 · Received January 11, 2013

    Report

    Report Number
    2031924-2013-00008
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 14, 2012
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K082944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 DURING A LENS IMPLANT, THE POSTERIOR CAPSULE TORE, THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY WITH ANOTHER MODEL LENS. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE. REFERENCE MDR #2031924-2013-00007 FOR THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18732 CRYSTALSERT CRYSTALENS DELIVERY SYSTEM MSS/IOL INSERTER/INJECTOR MSS BAUSCH & LOMB CI-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CRYSTALENS ACCOMODATING IOL