BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2143013 · Received June 23, 2011

    Report

    Report Number
    1119421-2011-00791
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    January 11, 2011
    Report Date
    May 24, 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
    TX, 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 CAN BE IDENTIFIED BY THE INVESTIGATION. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. CONCLUSION: BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS COMPLAINT AND BASED ON THESE FINDINGS THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED 05/25/2011 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED 05/26/2011. (B)(6).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED FOR A DIFFERENT MODEL BECAUSE THE PATIENT REPORTED MONOCULAR DIPLOPIA. FOLLOW UP INFORMATION WAS RECEIVED FROM THE SURGEON, WHO REPORTS THE EVENT RESOLVED FOLLOWING THE LENS EXCHANGE. AN UNAPPROVED VISCOELASTIC WAS USED DURING THE INITIAL IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT4 12001168

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention DISCOVISC