BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1514591 · Received October 16, 2009

    Report

    Report Number
    1119421-2009-00981
    Event Type
    Other
    Date Received
    October 16, 2009
    Date of Event
    April 1, 2009
    Report Date
    September 16, 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
    SD, 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. MEDICAL RECORDS WERE RECEIVED ON 09/21/2009. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    A SURGEON REPORTED AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON ALSO REPORTED THE PT WAS EXPERIENCING DECREASED NEAR VISION. THIS REPORT IS FOR THE RIGHT EYE. THE LEFT EYE HAS PREVIOUSLY BEEN REPORTED IN MANUFACTURER REPORT NUMBER 1119421-2009-00806.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD3 10766598

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other ASPIRIN| DEPOMEDROL INJECTION - EVERY 2 MONTHS| TOPROL| HYDROCHLOROTHIAZIDE| UNKNOWN ANTIBIOTIC| MULTIVITAMIN