BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 280181 · Received May 26, 2000

    Report

    Report Number
    1119421-2000-00484
    Event Type
    Other
    Date Received
    May 26, 2000
    Report Date
    April 27, 2000
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO PROVIDED BY THE SURGEON STATED THAT THE VISUAL EFFECTS DESCRIBED BY THE PT OCCUR IN THE RIGHT EYE AND BEGAN IMMEDIATELY FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS. THE SURGEON PRESCRIBED A -0.50 SOFT CONTACT LENS FOR THE AFFECTED EYE. BEST VA PRIOR TO IMPLANTATION WAS 20/50 AND WAS REPORTED TO BE 20/25 ON 09/02/1999.

    Description of Event or Problem · 1

    A CONSUMER REPORTS THAT, FOLLOWING CATARACT SURGERY, CONSUMER HAS BEEN EXPERIENCING POOR DIMENSIONAL VISION. THIS IS MOST NOTICEABLE AT DUCK AND HAS BEEN DESCRIBED AS EVERYTHING FLATTENING WITH HIGHS AND LOWS DISAPPEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. MA30BA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other