BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1789531 · Received August 6, 2010

    Report

    Report Number
    1119421-2010-00878
    Event Type
    Other
    Date Received
    August 6, 2010
    Date of Event
    May 20, 2010
    Report Date
    June 4, 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
    CA, US
    Reporter Occupation
    OTHER

    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 INFO WAS REQUESTED ON 06/04/2010, 06/07/2010, 06/08/2010, 06/11/2010, 07/08/2010, AND 08/03/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 07/07/2010. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "UNEXPECTED POSTOPERATIVE REFRACTION" (POSTOPERATIVE REFRACTION, UNEXPECTED). PRODUCT PROBLEM(S): "IOL OFF AXIS" (MALPOSITION OF DEVICE [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED THE PT HAD A HISTORY OF IRREGULAR ASTIGMATISM. IN A FOLLOW UP, THE SURGEON REPORTED THE IOL WAS OFF AXIS FROM THE INTENDED POSTOPERATIVE POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT5 10982126

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other VISCOAT