BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1840034 · Received September 15, 2010

    Report

    Report Number
    1119421-2010-01007
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 16, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 08/16/2010 AND 09/08/2010 BY MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "UNK" (NO INFO). PRODUCT PROBLEM(S): "DAMAGED" (DEFECTIVE ITEM [IOL (INTRAOCULAR LENS) IMPLANT]). A USER FACILITY REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DAMAGED. PT IMPACT REMAINS UNK. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT5 10976769

    Patients

    Seq Age Sex Outcome Treatment
    1