BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1963371 · Received January 14, 2011

    Report

    Report Number
    1119421-2011-00031
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    January 1, 2010
    Report Date
    December 16, 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
    NV, 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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. 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. (B)(4).

    Description of Event or Problem · 1

    AN ADMINISTRATOR REPORTED THAT A SURGEON EXPLANTED AN INTRAOCULAR LENS (IOL) BECAUSE THE PT COULD NOT TOLERATE THE IOL. IN A F/U, THE ADMIN AND THE SURGEON FURTHER CLARIFIED THAT THE PT EXPERIENCED DIPLOPIA WHICH RESOLVED AFTER IOL WAS EXCHANGED FOR A DIFFERENT MODEL LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT5 10989467

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention VISCOAT/PROVISC| MONARCH DELIVERY SYSTEM