BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1604283 · Received February 11, 2010

    Report

    Report Number
    1119421-2010-00121
    Event Type
    Other
    Date Received
    February 11, 2010
    Date of Event
    January 1, 2009
    Report Date
    January 12, 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
    FL, 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 INFO WAS REQUESTED ON 01/14/2010 AND 01/22/2010 BY FAX, MAIL AND PHONE. ADDITIONAL INFO WAS RECEIVED ON 01/14/2010, 01/21/2010 AND 01/22/2010 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    A SURGEON REPORTED AN UNEXPECTED ASTIGMATIC POSTOPERATIVE SURPRISE FOLLOWING INTRAOCULAR LENS IMPLANT SURGERY. LIMBAL RELAXING INCISIONS WERE PERFORMED DURING THE PROCEDURE WITH VERY LITTLE EFFECT. ADDITIONAL 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 10968274

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ARTIFICIAL TEARS