BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2170157 · Received June 24, 2011

    Report

    Report Number
    1119421-2011-00808
    Event Type
    Other
    Date Received
    June 24, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 27, 2011
    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

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ADD'L INFO WAS PROVIDED, WHICH INDICATED AN APPROVED CARTRIDGE WAS USED WITH A HANDPIECE. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. 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. ADD'L INFO HAS WAS REQUESTED ON 05/31/2011, 06/01/2011 AND 06/13/2011 BY MAIL AND PHONE. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 06/16/2011. (B)(4).

    Description of Event or Problem · 1

    A CORNEA COORDINATOR REPORTED THAT AN INTRAOCULAR LENS (IOL) ROTATED FOLLOWING SURGERY AND NOW THE PT IS REPORTING LIGHT SENSITIVITY. FOLLOW UP INFO WAS RECEIVED FROM THE SURGEON, WHO REPORTS THAT THE EVENT CONTINUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT5 10966779

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other