BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 1212771 · Received October 24, 2008

    Report

    Report Number
    1119421-2008-00837
    Event Type
    Other
    Date Received
    October 24, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 24, 2008
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    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 ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADD'L INFO WAS REQUESTED VIA FAX ON 09/26/2008 AND 10/08/2008, VIA MAIL ON 09/26/2008, AND VIA PHONE ON 10/08/2008. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 10/24/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED HIS PATIENT EXPERIENCED A FLIPPED AXIS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS MJP ALCON RESEARCH, LTD/HUNTINGTON SN60T5 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other