BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1660412 · Received April 14, 2010

    Report

    Report Number
    1119421-2010-00416
    Event Type
    Injury
    Date Received
    April 14, 2010
    Report Date
    March 15, 2010
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H3, 6: 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. ADD'L INFO WAS REQUESTED ON 03/19/2010, 03/22/2010, 03/25/2010, 04/02/2010, 04/05/2010, 04/06/2010, AND 04/08/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "UNEXPECTED POSTOPERATIVE REFRACTION" (POSTOPERATIVE REFRACTION, UNEXPECTED); "ANISOMETROPIA" (NO CODE AVAILABLE). PRODUCT PROBLEM(S): "MALFUNCTION" (NO INFO). A NURSE REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO A MALFUNCTION AND ANISOMETROPIA. THE IOL WAS EXCHANGED FOR THE SAME MODEL, DIFFERENT POWER LENS. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS MJP ALCON RESEARCH, LTD. / HUNTINGTON SN6AT5 10957902

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention