BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 222006 · Received April 27, 1999

    Report

    Report Number
    1119421-1999-00617
    Event Type
    Injury
    Date Received
    April 27, 1999
    Date of Event
    October 27, 1998
    Report Date
    March 30, 1999
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SURGEON STATES THAT A PT REPORTS A VISUAL DISURBANCE AFTER CATARACT SURGERY. THE INTRAOCULAR LENS (IOL) REMAINS IMPLANTED. THE PT'S VISUAL ACUITY WAS 20/40 ON 1/14/1999.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other