BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1629438 · Received March 10, 2010

    Report

    Report Number
    1119421-2010-00254
    Event Type
    Other
    Date Received
    March 10, 2010
    Date of Event
    January 1, 2010
    Report Date
    February 8, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE, THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFO WAS REQUESTED ON 02/09/2010, 02/15/2010, 02/22/2010, 02/23/2010, AND 03/04/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B) (4)

    Description of Event or Problem · 1

    A SURGICAL COORDINATOR REPORTED A PT SEEING RINGS AT NIGHT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW UP, THE SURGICAL COORDINATOR SPEAKING FOR THE SURGEON REPORTED, THE PT WAS DOING BETTER. THE SURGEON FELT, THE INITIAL PROBLEMS WERE DUE TO NORMAL NEUROADAPTATION. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other