BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 126939 · Received October 16, 1997

    Report

    Report Number
    1119421-1997-00103
    Event Type
    Injury
    Date Received
    October 16, 1997
    Date of Event
    July 29, 1997
    Report Date
    September 19, 1997
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS MAILED TO FDA ON: 2/4/1998. DISCLAIMER: THIS INFO IS SUBMITTED PURSUANT TO 21 CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. NUMBER OF PERSONS AFFECTED = 1.

    Description of Event or Problem · 1

    SURGEON REPORTS LENS WAS REPLACED DUE TO A STARBURST OF LIGHT IN VISION.

    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 57 YR Required Intervention