BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1053090 · Received May 23, 2008

    Report

    Report Number
    1119421-2008-00369
    Event Type
    Other
    Date Received
    May 23, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 25, 2008
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE THE LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED 04/30/2008 AND 05/05/2008 BY PHONE, FAX AND MAIL. THE SURGEON IS UNWILLING TO COMPLETE QUESTIONNAIRE OR PROVIDE ANY INFORMATION REGARDING THE LENS. THIS REPORT WAS MAILED TO FDA ON 05/23/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT TWO YEARS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT IS HAVING DIFFICULTY WITH READING AT NEAR VISION. THE SURGEON IS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other