BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1023603 · Received March 28, 2008

    Report

    Report Number
    1119421-2008-00191
    Event Type
    Other
    Date Received
    March 28, 2008
    Date of Event
    October 24, 2007
    Report Date
    February 29, 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
    MD, 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. ADDITIONAL INFO WAS REQUESTED 03/03/08 AND 03/07/08 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS REC'D. THIS REPORT WAS MAILED TO FDA ON: 03/28/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTS BLURRY CENTRAL VISION, HALOS AND GHOSTING IN THE LEFT EYE FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD/HUNTINGTON SN6AD3 10744200

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other