BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1530990 · Received November 6, 2009

    Report

    Report Number
    1119421-2009-01063
    Event Type
    Other
    Date Received
    November 6, 2009
    Date of Event
    October 1, 2009
    Report Date
    October 8, 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
    WI, 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 10/12/2009, 10/14/2009, AND 11/03/2009 BY PHONE, FAX, AND MAIL. MEDICAL RECORDS WERE RECEIVED ON 10/16/2009. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH UNEXPECTED POSTOPERATIVE OUTCOMES FOLLOWING BILATERAL IMPLANT SURGERIES. ADDITIONAL INFO HAS BEEN REQUESTED. 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 10933514

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other