BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2052568 · Received April 8, 2011

    Report

    Report Number
    1119421-2011-00392
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    January 25, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. THE PRODUCT WAS NOT RETURNED. 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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 03/14/2011, 03/25/2011, AND 04/04/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS REC'D ON (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED AN INTRAOCULAR LENS (IOL) WAS EXCHANGED. F/U INFORMATION WAS REC'D FROM SURGEON THAT THE IOL EXCHANGED DUE TO UNRESOLVED ASTIGMATISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT4 10872249

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention