BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1992857 · Received February 4, 2011

    Report

    Report Number
    1119421-2011-00074
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Report Date
    January 6, 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
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS RETURNED FOR ANALYSIS, AND THE REPORTED COMPLAINT OF FOLDING ISSUE COULD NOT BE VERIFIED. THE PRODUCT WAS DAMAGED AND THIS DAMAGE WAS NOT MENTIONED BY THE CUSTOMER. WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MANUFACTURING RELATED. A FOLD TEST WAS CONDUCTED WITH ACCEPTABLE RESULTS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ROOT CAUSE: NO ROOT CAUSE COULD BE DETERMINED FOR FOLDING ISSUE; HOWEVER, THE LENS WAS DAMAGED. WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MANUFACTURING RELATED. DUE TO THE PRESENCE OF SURGICAL SOLUTION, THE DAMAGE IS MOST RELATED TO CUSTOMER HANDLING. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. ADDITIONAL INFO WAS REQUESTED ON 01/07/2011 AND 01/28/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT AN INTRAOCULAR LENS (IOL) DID NOT FOLD CORRECTLY. PT IMPACT IS UNK. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT4 10986550

    Patients

    Seq Age Sex Outcome Treatment
    1