BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1624723 · Received March 5, 2010

    Report

    Report Number
    1119421-2010-00238
    Event Type
    Other
    Date Received
    March 5, 2010
    Date of Event
    June 30, 2009
    Report Date
    February 5, 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
    NY, 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 INFO WAS REQUESTED ON 02/15/2010 AND 02/24/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 02/24/2010. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED THAT A PT HAS CLOUDY VISION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. IN A FOLLOW-UP, THE SURGEON REPORTED THE PT HAS A PRE-EXISTING MACULAR SCAR. THE EVENT HAS NOT RESOLVED FOR THE PT. IN THE SURGEON'S OPINION, THE DEVICE DID NOT CAUSE/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 SN6AD1 10904921

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other VISCOELASTIC