BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1833836 · Received September 8, 2010

    Report

    Report Number
    1119421-2010-00995
    Event Type
    Other
    Date Received
    September 8, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 9, 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
    IN, US
    Reporter Occupation
    UNKNOWN

    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. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "DOUBLE VISION" (DIPLOPIA); "LIGHT AURAS" (VISUAL DISTURBANCES). PRODUCT PROBLEM(S): "NONE REPORTED" (NO CODE AVAILABLE [IOL (INTRAOCULAR LENS) IMPLANT]). A CONSUMER REPORTED HAVING DOUBLE VISION AND SEEING LIGHT AURAS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A F/U WITH THE CONSUMER, HE FURTHER CLARIFIED THAT HE SEES A SLIGHT SHADOWING WHEN READING IN LOW LIGHT CONDITIONS AND OCCASIONALLY NOTICES RING AROUND OBJECTS. HE STATED THAT HE IS SEEING EXCEPTIONALLY WELL AT ALL DISTANCES AND IS VERY PLEASED WITH HIS VISION. AT THE CONSUMER'S REQUEST, THE SURGEON WAS NOT CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 11013599

    Patients

    Seq Age Sex Outcome Treatment
    1 Other