BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1993420 · Received February 10, 2011

    Report

    Report Number
    1119421-2011-00092
    Event Type
    Other
    Date Received
    February 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 11, 2011
    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

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. NO SAMPLE WAS RETURNED. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 01/14/2011, 01/21/2011, AND 01/25/2011 BY PHONE, FAX, AND MAIL. THE SURGEON WAS UNWILLING TO COMPLETE THE QUESTIONNAIRE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON WAS UNWILLING TO COMPLETE THE QUESTIONNAIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT4 10961040

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other