BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2111166 · Received May 26, 2011

    Report

    Report Number
    1119421-2011-00631
    Event Type
    Other
    Date Received
    May 26, 2011
    Report Date
    April 25, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: 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. THE SAMPLE WAS NOT RETURNED. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. 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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED 04/26/2011 AND 05/13/2011 BY FAX, MAIL AND PHONE. ADDITIONAL INFORMATION WAS RECEIVED 05/20/2011 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED HAVING A PATIENT WHOSE INTRAOCULAR LENS (IOL) FLIPPED ITS AXIS FOLLOWING IMPLANT SURGERY, RESULTING IN A REFRACTIVE SURPRISE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON, WHO REPORTS THAT THE PATIENT IS REQUESTING SURGICAL INTERVENTION TO CORRECT THE REFRACTIVE SURPRISE. ADDITIONAL INFORMATION 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 SN6AT4 10900613

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other