BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1518815 · Received October 23, 2009

    Report

    Report Number
    1119421-2009-01007
    Event Type
    Injury
    Date Received
    October 23, 2009
    Date of Event
    September 1, 2009
    Report Date
    September 24, 2009
    Manufacturer
    ALCON RESEARCH, LTD./ HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED, BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED 09/30/2009, 10/06/2009, 10/12/2009, AND 10/14/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 10/23/2009.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH AN INTRAOCULAR LENS (IOL) THAT HAD ROTATED OFF AXIS FOLLOWING IOL IMPLANT SURGERY. AN ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED TO RETURN THE IOL TO THE CORRECT POSITION. THE SURGEON REPORTED THE PATIENT ALSO HAD AN UNEXPECTED POSTOPERATIVE REFRACTION DUE TO A CALCULATION ERROR. ADDITIONAL INFORMATION 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 SN6AT4 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention