BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2932233 · Received January 25, 2013

    Report

    Report Number
    1119421-2013-00075
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    October 29, 2012
    Report Date
    December 28, 2012
    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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AN INTRAOCULAR LENS (IOL) ROTATED AFTER IMPLANTATION DUE TO A DEFECT. THE IOL WAS EXCHANGED FOR A SAME MODEL LENS OF DIFFERENT POWER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36177 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD / HUNTINGTON SN6AT3 11077635

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention