BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1409636 · Received July 1, 2009

    Report

    Report Number
    1119421-2009-00623
    Event Type
    Injury
    Date Received
    July 1, 2009
    Date of Event
    May 1, 2009
    Report Date
    June 1, 2009
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 06/05/2009, 06/08/2009, 06/15/2009, 06/22/2009, AND 06/26/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. MEDICAL RECORDS WERE RECEIVED ON 06/04/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS OFF AXIS FOLLOWING IOL IMPLANT SURGERY. THE SURGEON REPORTED EDEMA WAS NOTED AT THE ONE WEEK POSTOPERATIVE VISIT AND TREATED WITH MEDICATIONS. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS MJP ALCON RESEARCH, LTD. / HUNTINGTON SN6AT5 10871007

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention FLOMAX