BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2202079 · Received August 5, 2011

    Report

    Report Number
    1119421-2011-00956
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    June 2, 2011
    Report Date
    July 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
    IL, 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. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. CONCLUSION: BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THE FINDINGS THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 07/06/2011, 07/13/2011, 07/20/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 07/27/2011. ADD'L INFO WAS RECEIVED IN A FOLLOW UP PHONE CALL ON 08/02/2011. (B)(4).

    Description of Event or Problem · 1

    A BIOMETRIST REPORTED A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE DUE TO THE LENS BEING OFF AXIS. IN A FOLLOW UP PHONE CALL WITH THE BIOMETRIST, IT WAS REPORTED THE LENS WAS ROTATED IN A SECONDARY SURGICAL PROCEDURE AND THE PT IS DOING WELL POSTOPERATIVELY WITH A UCVA OF 20/25 ON THE FIRST POSTOPERATIVE DAY. IN A FOLLOW-UP, THE SURGEON DOES NOT FEEL THE IOL CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT5 11034212

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention PROVISC| VISCOAT