BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 1413313 · Received July 10, 2009

    Report

    Report Number
    1119421-2009-00648
    Event Type
    Injury
    Date Received
    July 10, 2009
    Date of Event
    January 1, 2009
    Report Date
    June 10, 2009
    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 INFORMATION WAS REQUESTED ON 06/11/2009, 06/12/2009, 06/19/2009, 06/24/2009, 06/29/2009, 07/01/2009 AND 07/02/2009 BY PHONE, FAX, AND MAIL. THE SURGEON WAS UNWILLING TO RETURN THE QUESTIONNAIRE.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT EXPERIENCING POOR VISION AND GLARE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED THE PATIENT'S VISUAL ACUITY HAD IMPROVED WITH TIME, BUT THE GLARE HAD CONTINUED. A YAG LASER PROCEDURE WAS PERFORMED AND THE GLARE BECAME WORSE. THE SURGEON REPORTED THE PATIENT HAD A LASIK PROCEDURE PERFORMED BY A DIFFERENT PHYSICIAN. THE SURGEON WAS UNWILLING TO RETURN THE QUESTIONNAIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOUCLAR LENS MJP ALCON RESEARCH. LTD. / HUNTINGTON SN60T4 145036

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention