BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1674661 · Received May 3, 2010

    Report

    Report Number
    1119421-2010-00489
    Event Type
    Other
    Date Received
    May 3, 2010
    Date of Event
    January 1, 2010
    Report Date
    April 6, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. ADDITIONAL INFORMATION WAS REQUESTED ON 04/08/2010, 04/12/2010, 04/13/2010, 04/16/2010, 04/21/2010, AND 04/23/2010 BY PHONE, FAX, AND MAIL. THE SURGEON WAS UNWILLING TO COMPLETE THE QUESTIONNAIRE. MEDICAL RECORDS WERE RECEIVED ON 04/06/2010. (B) (4). (B) (4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): 'UNEXPECTED POSTOPERATIVE REFRACTION" (POSTOPERATIVE REFRACTION, UNEXPECTED). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFORMATION [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON WAS UNWILLING TO COMPLETE THE QUESTIONNAIRE. THERE ARE THIRTY NINE MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS TWO OF THIRTY NINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS MJP ALCON RESEARCH, LTD. / HUNTINGTON SN6AT5 10984364

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other