BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1983128 · Received February 4, 2011

    Report

    Report Number
    1119421-2011-00080
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 6, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE, THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ROOT CAUSE: NO LOT/SERIAL NUMBER OR SAMPLE WAS RETURNED BY THE CUSTOMER. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. 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. ADD'L INFO WAS REQUESTED ON 01/10/2011 AND 01/24/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. ADD'L INFO WAS RECEIVED IN A F/U PHONE CALL ON 02/03/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED, A PT WITH RESIDUAL ASTIGMATISM FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED THAT THE IOL IS OFF AXIS. IN A F/U PHONE CALL WITH THE SURGEON, THE IOL WAS ROTATED AND THE PT HAS BEEN DOING WELL FOLLOWING THE ROTATION PROCEDURE. THE SURGEON REPORTED THAT HE IS NOT BLAMING THE 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 SN6AT5 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention