BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1649738 · Received March 24, 2010

    Report

    Report Number
    1119421-2010-00336
    Event Type
    Other
    Date Received
    March 24, 2010
    Date of Event
    December 1, 2009
    Report Date
    February 22, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 02/22/2010, 02/23/2010, 03/01/2010, AND 03/12/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "POOR VISION AT ALL DISTANCES" (VISION, IMPAIRED); "VISION IS NOT SHARP" (VISION, IMPAIRED); "POOR CONTRAST VISION"; "GLARE" (VISUAL DISTURBANCES); "EYES WATERING IN BRIGHT LIGHTS" (TEARING, EXCESSIVE); "UNABLE TO SEE IN DIM LIGHT CONDITIONS" (VISION, IMPAIRED). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFORMATION [IOL (INTRAOCULAR LENS) IMPLANT]). A CONSUMER REPORTED POOR VISION AT ALL DISTANCES, VISION IS NOT SHARP, POOR CONTRAST VISION, GLARE AND EYES WATER IN BRIGHT LIGHTS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. THE VISION ISSUES WERE AFFECTING HIS DAILY ACTIVITIES INCLUDING WORKING, DRIVING AND TAKING CARE OF HIS MOTHER. HE HAS BEEN GIVEN PRESCRIPTION GLASSES WITH BIFOCALS; HOWEVER, THEY DO NOT CORRECT HIS VISION ISSUES. ADDITIONAL INFORMATION WAS RECEIVED FROM THE OPHTHALMIC SURGEON'S OFFICE. IT WAS REPORTED THAT THE PATIENT SEES 20/20 WITH GLASSES. THE PATIENT HAS VOICED HIS DISSATISFACTION REGARDING HIS VISION TO THEM. THIS IS ONE OF TWO MEDICAL DEVICE REPORTS BEING FILED FOR THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE. THE LEFT EYE HAS PREVIOUSLY BEEN REPORTED IN 1119421-2010-00056.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10870245

    Patients

    Seq Age Sex Outcome Treatment
    1 Other