BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF TORIC

    MDR report key: 1230408 · Received November 7, 2008

    Report

    Report Number
    1119421-2008-00888
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 9, 2008
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 10/10/2008 BY MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 10/27/2008.

    Description of Event or Problem · 1

    A USER FACILITY REPORTS THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A DEFECT WAS NOTED ON THE LENS. IT WAS REMOVED AND REPLACED IMMEDIATELY. THERE WAS NO IMPACT/INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60T4 10828344

    Patients

    Seq Age Sex Outcome Treatment
    1 NA