BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 2007698 · Received February 25, 2011

    Report

    Report Number
    2031924-2011-00045
    Event Type
    Injury
    Date Received
    February 25, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INFO RECEIVED, THE INTRAOCULAR LENS IS IMPLANTED. NO PRODUCT INFO (SUCH AS MODEL NUMBER, CATALOG NUMBER, LOT NUMBER OR SERIAL NUMBER) HAS BEEN PROVIDED; IN ADDITION, THE DEVICE WAS NOT RETURNED TO BAUSCH + LOMB FOR EVALUATION. THEREFORE, NO INVESTIGATION COULD BE PERFORMED.

    Description of Event or Problem · 1

    BAUSCH + LOMB, INC. RECEIVED A NOTIFICATION FROM (B)(6) DEPARTMENT OF AGRICULTURE & CONSUMER SERVICES, INDICATING THAT A CONSUMER COMPLAINED OF RETINAL SWELLING AND POOR VISION RELATED TO THE LEFT EYE FOLLOWING CATARACT SURGERY WITH IMPLANTATION OF A CRYSTALENS IOL. ACCORDING TO THE CONSUMER, SHE CONSULTED SEVERAL MEDICAL SPECIALISTS AND WAS ADVISED THAT THE CRYSTALENS HAD FLEXED, CONTACTING THE IRIS AND CAUSING THE RETINAL SWELLING AND POOR VISION. THE CONSUMER ALSO INDICATED THAT THE OUTLOOK ON REMOVING THE LENS IS VERY POOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH + LOMB 4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other