BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2230524 · Received August 12, 2011

    Report

    Report Number
    1119421-2011-00973
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 13, 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

    EVAL SUMMARY: PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE COULD NOT 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 THESE FINDINGS THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. ADD'L INFO WAS REQUESTED ON 07/14/2011 07/18/2011 BY FAX, PHONE AND MAIL. THE SURGEON IS UNWILLING TO PROVIDE ANY ADD'L INFO. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THE LENS WAS FOUND TO BE OFF AXIS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE STATED THE PT COMPLAINED OF SEEING SHADOWS. HE REPORTED AT THIS TIME HE IS UNSURE IF HE IS GOING TO ROTATE OR EXCHANGE THE IOL. ADD'L INFO HAS BEEN REQUESTED; HOWEVER, THE SURGEON IS UNWILLING TO PROVIDE ANY ADD'L DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT5 10913049

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other