BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYCOF

    MDR report key: 1521490 · Received November 4, 2009

    Report

    Report Number
    1119421-2009-01040
    Event Type
    Injury
    Date Received
    November 4, 2009
    Date of Event
    September 30, 2009
    Report Date
    October 5, 2009
    Manufacturer
    ALCON MANUFACTURING, 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
    AZ, 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 NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 10/14/2009, 10/19/2009, AND 10/29/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAD NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 11/04/2009.

    Description of Event or Problem · 1

    A NURSE REPORTED THAN AT INTRAOCULAR LENS (IOL) WAS EXCHANGED, DUE TO A BROKEN HAPTIC. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYCOF INTRAOCULAR LENS HQL ALCON MANUFACTURING, LTD. / HUNTINGTON SN60WF 10922170

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention