BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 268422 · Received March 10, 2000

    Report

    Report Number
    1119421-2000-00222
    Event Type
    Injury
    Date Received
    March 10, 2000
    Report Date
    February 9, 2000
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED THAT PERFORMING AN INTRAOCULAR LENS EXCHANGE FOR A PT THAT COMPLAINED OF VISUAL DISTRUBANCES FOLLOWING CATARACT SURGERY. A YAG CAPSULOTOMY WAS PERFORMED IN SEPTEMBER 1999 WITHOUT RELIEF OF SYMPTOMS. THE LENS WAS EXCHANGED 12/09/1999 WITH RELIEF OF SYMPTOMS. THE VISUAL ACUITY WITHOUT CORRECTION IS 20/20, AND PT IS DOING WELL.

    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 UNKNOWN Required Intervention