BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1202785 · Received October 16, 2008

    Report

    Report Number
    1119421-2008-00809
    Event Type
    Other
    Date Received
    October 16, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 16, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 VIA PHONE ON 09/16/2008, 09/17/2008, AND 09/18/2008 AND VIA FAX AND MAIL ON 09/17/2008. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT EXPERIENCED A HYPEROPIC SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE DOES NOT BELIEVE THE EVENT IS RELATED TO THE IOL. ADDITIONAL INFO WAS REQUESTED.

    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 NI Other