BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTORE

    MDR report key: 1611655 · Received February 18, 2010

    Report

    Report Number
    1119421-2010-00144
    Event Type
    Injury
    Date Received
    February 18, 2010
    Date of Event
    January 1, 2010
    Report Date
    January 19, 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
    IL, 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 02/04/2010, 02/05/2010, 02/15/2010, AND 02/18/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. MEDICAL RECORDS WERE RECEIVED ON 02/18/2010. (B) (4). (B) (4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH POOR INTERMEDIATE VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED THE PT WAS EXPERIENCING FLUCTUATING AND FILMY VISION THAT WAS INTERMITTENT. THE PT WAS ALSO EXPERIENCING HALOS AND GLARE FROM CAR HEADLIGHTS. THE SURGEON TREATED THE PT WITH MEDICATIONS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTORE INTEROCULAR LENS MFK ALCON RESEARCH. LTD. / HUNTINGTON SN6AD3 10800591

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention VIGAMOX PREOPERATIVELY| LEVOTHYROID| FLONASE| NEVANAC| ARTIFICIAL TEARS