BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 982689 · Received January 18, 2008

    Report

    Report Number
    1119421-2008-00024
    Event Type
    Injury
    Date Received
    January 18, 2008
    Date of Event
    January 1, 2007
    Report Date
    December 19, 2007
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED 12/20/2007, 12/21/2007 AND 01/08/2008 BY PHONE, MAIL AND FAX. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTS A BILATERAL INTRAOCULAR LENS (IOL) EXPLANT WAS PERFORMED DUE TO NEGATIVE DYSPHOTOPSIA. ADDITIONAL INFORMATION, INCLUDING PATIENT STATUS, HAS BEEN REQUESTED. THERE ARE TWO REPORTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SA60D3 937511

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Required Intervention