BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 1023612 · Received March 28, 2008

    Report

    Report Number
    1119421-2008-00201
    Event Type
    Other
    Date Received
    March 28, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 27, 2008
    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
    CA, 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 ARE NO OTHER REPORTS IN THIS LOT. ADD'L INFO WAS REQUESTED ON 03/04/2008 BY PHONE AND ON 03/07/2008 BY MAIL AND BY FAX. ADD'L INFO WAS RECEIVED ON 03/19/2008.

    Description of Event or Problem · 1

    A FACILITY REPORTER A PT WAS IMPLANTED WITH AN INTRAOCULAR LENS (IOL) AND HAD AN UNEXPECTED OUTCOME. THE PT'S CYLINDER DID NOT CHANGE AS EXPECTED. THE PT WAS REPORTED TO BE HAPPY WITH THEIR OUTCOME. THE IOL REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./ HUNTINGTON SN60T3 10746094

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other