BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1822549 · Received August 27, 2010

    Report

    Report Number
    1119421-2010-00937
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    January 1, 2009
    Report Date
    July 30, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 AND REC'D. NO FURTHER INFORMATION IS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "HALOS DAY AND NIGHT" (HALO). PRODUCT PROBLEM(S): "NONE REPORTED" ( NO INFORMATION [IOL(INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED A PT EXPERIENCING HALOS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES WHICH WERE CLEAR LENS EXTRACTIONS. THE LENSES WERE REPLACED AND THE EVENT RESOLVED. NO FURTHER INFORMATION IS EXPECTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE. THE REPORT FOR THE LEFT EYE WAS FILED AS MFR REPORT #1119421-2010-00788.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 10845133

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention VISCOELASTICS| DELIVERY SYSTEM