BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1031124 · Received April 18, 2008

    Report

    Report Number
    1119421-2008-00259
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 20, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN ON OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED 03/21/2008 AND 04/07/2008 BY MAIL, FAX AND PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 04/18/2008.

    Description of Event or Problem · 1

    A TECHNICIAN REPORTS THAT TWO YEARS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT REPORTS FOGGY VISION. A YAG CAPSULOTOMY WAS PERFORMED BUT THE PT REPORTS THERE WAS NO IMPROVEMENT IN HIS VISION. THE SURGEON BELIEVES THE VISUAL COMPLAINTS MAY BE RELATED TO THE SURFACE OF THE LENS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MA60AC 677716

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention