BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 277963 · Received May 12, 2000

    Report

    Report Number
    1119421-2000-00427
    Event Type
    Other
    Date Received
    May 12, 2000
    Report Date
    April 12, 2000
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING CATARACT SURGERY A PT DESCRIBES SEEING A DARK AREA IN PT TEMPORAL VISION. THE ASSOCIATION BETWEEN THIS EVENT AND THE INTRAOCULAR LENS (IOL) IS NOT KNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other