BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1587841 · Received January 15, 2010

    Report

    Report Number
    1119421-2010-00022
    Event Type
    Other
    Date Received
    January 15, 2010
    Date of Event
    January 1, 2009
    Report Date
    December 18, 2009
    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
    AZ, 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 INFORMATION WAS REQUESTED 12/18/2009, 12/21/2009 AND 01/06/2010 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED GLARE FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO REPORTS ASSOCIATED WITH THIS EVENT; THIS REPORT IS FOR THE FIRST EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10938178

    Patients

    Seq Age Sex Outcome Treatment
    1 Other