BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 1414363 · Received July 15, 2009

    Report

    Report Number
    1119421-2009-00679
    Event Type
    Injury
    Date Received
    July 15, 2009
    Date of Event
    June 17, 2009
    Report Date
    June 15, 2009
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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. ADDITIONAL INFORMATION WAS REQUESTED ON 06/17/2009, 06/19/2009, 06/24/2009, 06/29/2009, 06/30/2009, AND 07/01/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO AN UNEXPECTED POSTOPERATIVE REFRACTION. UPON EXAMINATION, THE IOL WAS NOTED TO HAVE ROTATED. THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL IOL. THE SURGEON REPORTED THE PATIENT IS "SEEING EXCELLENT" FOLLOWING THE EXCHANGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS MJP ALCON RESEARCH, LTD. SN60T4 10719909

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention