BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1243157 · Received November 21, 2008

    Report

    Report Number
    1119421-2008-00944
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    April 4, 2008
    Report Date
    October 22, 2008
    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, 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 10/27/2008 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 10/31/2008. THIS REPORT WAS MAILED TO FDA ON: 11/21/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTS DOUBLE VISION, BLURRY VISION, AND SEES A SMUDGE BELOW THINGS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE DOUBLE VISION RESOLVED FOLLOWING IOL IMPLANT SURGERY IN THE FELLOW EYE. SHE WAS GIVEN A PRESCRIPTION FOR GLASSES, BUT IT DID NOT HELP MUCH. ALSO, LENS REPOSITIONING, YAG LASER, AND PUPILLOPLASTY WERE PERFORMED. IN A FOLLOW-UP, THE SURGEON STATES THE PATIENT'S VISION IS GOOD AND THAT, IN HER OPINION, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. 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 SN60D3 10716763

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention VISCOAT