BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1822423 · Received August 26, 2010

    Report

    Report Number
    1119421-2010-00936
    Event Type
    Other
    Date Received
    August 26, 2010
    Date of Event
    June 8, 2010
    Report Date
    July 27, 2010
    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
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 07/27/2010, 07/28/2010, 08/02/2010, 08/03/2010, 08/10/2010, AND 08/19/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 08/16/2010. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "SIGNIFICANT PROBLEMS WITH LIGHTS" (VISUAL DISTURBANCES). PRODUCT PROBLEM(S): "STRIATIONS" (NO CODE AVAILABLE [IOL (INTRAOCULAR LENS) IMPLANT]); "UNAPPROVED VISCOELASTIC" (USE OF DEVICE ISSUE). A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A CORNEAL SPECIALIST FOUND STRIATIONS IN BOTH IOLS WHICH WERE CAUSING THE CONSUMER PROBLEMS WITH LIGHTS, ESPECIALLY WHEN DRIVING AT NIGHT. THE CONSUMER REPORTED PROBLEMS WITH GLARE. HIS SURGEON TOLD HIM THAT SHE OBSERVED FIBERS ON THE IOLS. THE SURGEON REPORTED THAT SHE GAVE THE CONSUMER A TRIAL OF MEDICATIONS IN AN ATTEMPT TO IMPROVE HIS PROBLEMS WITH GLARE. THE CONSUMER HAS BEEN REFERRED TO ANOTHER OPHTHALMIC SURGEON WHO DIAGNOSED HIM WITH WRINKLING OF THE POSTERIOR CAPSULE VERSUS IOL STRIATIONS. IN A FOLLOW UP, THE EVENT CONTINUES. AN UNAPPROVED VISCOELASTIC WAS USED DURING THE IMPLANT PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT4 10989394

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other HEALON| MONARCH CARTRIDGE D