BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2081370 · Received April 22, 2011

    Report

    Report Number
    1119421-2011-00478
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 24, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: NO SAMPLE WAS RECEIVED FOR INVESTIGATION. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: ROOT CAUSE COULD NOT BE IDENTIFIED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 03/25/2011 AND 04/06/2011 BY MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 04/12/2011. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS NOTED TO HAVE A CRACK. THE LENS WAS REMOVED AND REPLACED DURING THE SAME SURGERY. IN A F/U, THE NURSE REPORTED THAT THERE WAS NO IMPACT OR INJURY TO THE PT. IT WAS ALSO INDICATED THAT AN UNAPPROVED VISCOELASTIC WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT5 10913064

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR MONARCH DELIVERY SYSTEM| HEALON GV