BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 2170089 · Received June 17, 2011

    Report

    Report Number
    1119421-2011-00761
    Event Type
    Other
    Date Received
    June 17, 2011
    Date of Event
    November 23, 2010
    Report Date
    May 20, 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
    Reporter Occupation
    NOT APPLICABLE

    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: NO ROOT CAUSE COULD 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 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 HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SHE IS ALLERGIC TO HER LENSES (IOL) FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. SHE ALSO REPORTED INFLAMMATION, SWELLING AND UVEITIS. ADDITIONALLY, SHE STATES HER ASTIGMATISM HAS WORSENED FOLLOWING THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/ HUNTINGTON SN60T3 10811263

    Patients

    Seq Age Sex Outcome Treatment
    1 Other