BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1833919 · Received September 9, 2010

    Report

    Report Number
    1119421-2010-00989
    Event Type
    Other
    Date Received
    September 9, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ALCON RESEARCH, LTD/ HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    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 A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED 08/12/2010 AND 08/30/2010 BY FAX, MAIL AND PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "REFRACTIVE SURPRISE" (POST OPERATIVE REFRACTION, UNEXPECTED). PRODUCT PROBLEM(S): "LENS ROTATED" (MALPOSITION OF DEVICE [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED A PATIENT WITH REFRACTIVE SURPRISE DUE TO LENS ROTATION FOLLOWING INTRAOCULAR LENS (IOL) SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/ HUNTINGTON SN6AT5 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other