BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3152623 · Received June 5, 2013

    Report

    Report Number
    1119421-2013-00602
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    January 16, 2013
    Report Date
    May 6, 2013
    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
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN MADE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED SHE EXPERIENCED FUZZY VISION, HALOS AND DISTORTED VISUAL ACUITY FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HER DISTANCE AND NEAR VISION WERE NOT SATISFACTORY TO HER EXPECTATIONS. THE SURGERY TREATED HER WITH LASIK AND GAVE HER A PRESCRIPTION FOR EYEGLASSES. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE SURGEON. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247888 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 12093676

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention