BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2060994 · Received April 1, 2011

    Report

    Report Number
    1119421-2011-00369
    Event Type
    Other
    Date Received
    April 1, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 3, 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 RECORDS 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 COMPLAINS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON (B)(6) 2011 AND (B)(6) 2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 04/01/2011. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED A PT WITH AN UNEXPECTED OUTCOME FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADD'L INFO 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 12003394

    Patients

    Seq Age Sex Outcome Treatment
    1 Other