BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONARCH IOL DELIVERY SYSTEM-CARTRIDGE

    MDR report key: 380989 · Received March 7, 2002

    Report

    Report Number
    1119421-2002-00078
    Event Type
    Other
    Date Received
    March 7, 2002
    Report Date
    February 5, 2002
    Manufacturer
    ALCON LABORATORIES, INC./HUNTINGTON
    Product Code
    KYB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON REPORTS THE PT'S VISION WAS 20/20-2 FOLLOWING INTRAOCULAR LENS IMPLANTATION, HOWEVER THE PT WAS UNHAPPY WITH HER OUTCOME. THE SURGEON EXPLANTED THE LENS IN 2002 AND IMPLANTED ANOTHER LENS.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS, SHE NOTED CENTRAL OPACITY WITH FINE LINES ON THE ANTERIOR SURFACE OF THE OPTIC. SHE FELT THE LENS BECAME DAMAGED IN THE CARTRIDGE OF THE IOL DELIVERY SYSTEM. THE LENS REMAINS IMPLANTED. THE PATIENT COMPLAINS OF GLARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARCH IOL DELIVERY SYSTEM-CARTRIDGE LENS GUIDE KYB ALCON LABORATORIES, INC./HUNTINGTON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other