BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1002281 · Received February 22, 2008

    Report

    Report Number
    1119421-2008-00091
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 16, 2007
    Report Date
    January 25, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE ARE NO OTHER REPORTS IN THE LOT. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. ADD'L INFO WAS REQUESTED ON 01/29/2008 BY FAX AND BY MAIL.

    Description of Event or Problem · 1

    CONSUMER REPORTED HIS INTRAOCULAR LENS (IOL) WAS EXPLANTED AND REPLACED WITH ANOTHER IOL DUE TO A LENS POWER ISSUE. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWO MEDWATCH REPORTS BEING FILED FOR THIS CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SA60AT 124238

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Required Intervention