BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 287925 · Received July 25, 2000

    Report

    Report Number
    MW1019397
    Event Type
    Other
    Date Received
    July 25, 2000
    Date of Event
    March 12, 1997
    Report Date
    July 19, 2000
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IMMEDIATELY FOLLOWING CATARACT REMOVAL AND IMPLANTATION OF IOL'S, VISION GREATLY IMPROVED IN BOTH EYES. LEFT MORE LIGHT SENSITIVE AND IN CERTAIN LIGHTS APPEARANCE OF MULTI-FACETED FLASHING LIGHT SEEN BY OTHERS AND PT IN A MIRROR. VERY DISTURBING TO PT WHEN SEEN. LATELY, VISION IS RETURNING TO PRE-CATARACT REMOVAL, SEEING THROUGH CLOUDS, BLURRY, PRINTING ALMOST DOUBLE, EXTREME LIGHT SENSITIVITY IN LEFT LENS, REFLECTIONS, SIMPLE HALOS IN RT EYE. HUGE STARBURSTS IN LEFT. RETURNING TO LIMITATIONS PREVIOUSLY EXPERIENCED WITH CATARACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF OPTICAL IMPLANTS HQL ALCON LABORATORIES, INC. R) = MA60BM *
    2 ACRYSOF OPTICAL IMPLANTS HQL ALCON LABORATORIES, INC. L) = MA60BM *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other 2. 06/20/2000| 1. 05/16/2000,