BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1716500 · Received June 9, 2010

    Report

    Report Number
    1119421-2010-00667
    Event Type
    Injury
    Date Received
    June 9, 2010
    Date of Event
    January 1, 2010
    Report Date
    May 10, 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
    NC, 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 #. ADDITIONAL INFO WAS REQUESTED ON 05/18/2010, 05/20/2010, AND 05/26/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. MEDICAL RECORDS WERE RECEIVED ON 05/20/2010. (B) (4).(B) (4).(B) (4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "UNEXPECTED POSTOPERATIVE REFRACTION" (POSTOPERATIVE REFRACTION, UNEXPECTED); "IRITIS" (IRITIS); "BLURRY VISION" (BLURRED VISION). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFO [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. MEDICAL RECORDS WERE REQUESTED AND RECEIVED. ACCORDING TO THE MEDICAL RECORDS, THE PT HAD A HISTORY OF HYPERTENSION AND ASTIGMATISM (PRE-EXISTING). FOLLOWING THE IOL IMPLANT PROCEDURE, THE PT REPORTED HER DISTANCE VISION WAS NOT CLEAR. THE SURGEON NOTED RESIDUAL ASTIGMATISM. ACCORDING TO THE MEDICAL RECORDS, THE PT WAS DIAGNOSED WITH IRITIS AND TREATED WITH MEDICATIONS. FOLLOWING TREATMENT, THE PT STATED SHE HAD BLURRY VISION AT NEAR AND DISTANCE. THE PT REPORTED HER EYE FELT BETTER FOLLOWING TREATMENT, BUT HER VISION REMAINED BLURRY. 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 SN6AT4 10974377

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention POTASSIUM| COD LIVER OIL| TAMOFLOXIN| PROVASTATIN| ATENOLOL| SUBTENONS KENALOG INJECTION| VIT D| MAGNESIUM