BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2020364 · Received March 11, 2011

    Report

    Report Number
    1119421-2011-00276
    Event Type
    Injury
    Date Received
    March 11, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 14, 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
    OH, 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. ROOT CAUSE: THE ROOT CAUSE COULD NOT BE DETERMINED. 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 SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 03/07/2011 AND 03/08/2011 BY PHONE, FAX AND MAIL. ADD'L INFO WAS REC'D ON 03/07/2011 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED FOR A DIFFERENT TYPE LENS. IN A F/U WITH THE MATERIALS MANAGER, IT WAS REPORTED THAT THE SURGEON IMPLANTED THE INITIAL MODEL IN AN ATTEMPT TO CORRECT THE PT'S IRREGULAR ASTIGMATISM SECONDARY TO A CORNEAL TRANSPLANT PERFORMED IN THE PAST. FOLLOWING THE INITIAL IMPLANT, THE PT REPORTED DECREASE VISUAL FUNCTION DUE TO DYSPHOTOPSIA. THE SURGEON DOES NOT BLAME THE IOL FOR THE EVENT, AS THIS WAS AN OFF LABEL USAGE OF THE DEVICE. ADD'L 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 SN6AT5 10937889

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention