BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2063820 · Received April 15, 2011

    Report

    Report Number
    1119421-2011-00412
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 16, 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
    MI, US
    Reporter Occupation
    NURSE

    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 MGMT PERSONNEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON (B)(4) 2011 AND (B)(4) 2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4). THIS REPORT WAS MAILED TO FDA ON: (B)(4) 2011. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO AN UNEXPECTED POSTOPERATIVE REFRACTION DUE TO POOR PREOPERATIVE WORK UP. THE IOL WAS REPLACED WITH THE SAME MODEL, DIFFERENT POWER LENS. 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 SN6AT3 10989324

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention