BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1519596 · Received October 30, 2009

    Report

    Report Number
    1119421-2009-01020
    Event Type
    Injury
    Date Received
    October 30, 2009
    Date of Event
    August 31, 2009
    Report Date
    September 30, 2009
    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
    TX, US
    Reporter Occupation
    UNKNOWN

    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. ADD'L INFO WAS REQUESTED ON 09/30/2009, 10/21/2009, 10/28/2009, AND 10/29/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 10/30/2009.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DUE TO A CRACK BEING NOTED IN THE IOL AFTER INSERTION. IN A FOLLOW UP, A NURSE REPORTED THE INCISION WAS ENLARGED. ADD'L INFO HAD BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS MJP ALCON RESEARCH, LTD. / HUNTINGTON SN6AT3 10904671

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention