BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1891593 · Received October 29, 2010

    Report

    Report Number
    1119421-2010-01179
    Event Type
    Other
    Date Received
    October 29, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 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
    TX, 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 10/22/2010 BY PHONE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT EXPERIENCING GLARE AND STARBURSTS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PT REPORTED THAT THINGS WERE TOO BRIGHT, BUT SUNGLASSES HELPED AND THERE WERE MILD STARBURSTS AROUND LIGHTS AT NIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 11019270

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other