BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 261423 · Received February 4, 2000

    Report

    Report Number
    1119421-2000-00102
    Event Type
    Other
    Date Received
    February 4, 2000
    Report Date
    January 6, 2000
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO PROVIDED BY THE CONSUMER STATED THE INTRAOCULAR LENS (IOL) WAS EXCHANGED WITH A DIFFERENT IOL MODEL. THE GLARE SYMPTOMS HAVE IMPROVED.

    Description of Event or Problem · 1

    A CONSUMER REPORTS THAT AFTER CATARACT SURGERY AND INTRAOCULAR LENS (IOL) IMPLANT CONSUMER SEES A "SCATTERING OF LIGHT IN LOW LIGHT CONDITIONS FROM A SINGLE LIGHT SOURCE, SUCH AS A LIGHT BULB". VISUAL ACUITY IS 20/15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES MA60BM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other