BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2103776 · Received May 19, 2011

    Report

    Report Number
    1119421-2011-00619
    Event Type
    Other
    Date Received
    May 19, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 19, 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
    VA, 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 ON 04/26/2011, 05/06/2011, AND 05/16/2011 BY PHONE, FAX, AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED ON 05/06/2011 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW-UP, THE TECHNICIAN REPORTED THAT THE LENS ORIENTATION IS OFF AXIS THUS ACCOUNTING FOR THE UNEXPECTED OUTCOME. SHE ALSO STATED THAT THE PATIENT IS NOT ABLE TO SEE BETTER THAN 20/30; AND THAT THERE IS NO DOCUMENTED PATHOLOGY THAT ACCOUNTS FOR THIS DECREASED IN BCVA. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE. THE REPORT FOR THE RIGHT EYE WAS FILED UNDER MFR REPORT # 1119421-2011-00528.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH LTD./HUNTINGTON SN6AT4 10940169

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other