BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 1002279 · Received February 22, 2008

    Report

    Report Number
    1119421-2008-00086
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 16, 2008
    Report Date
    January 25, 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
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE REPORTER DID NOT PROVIDE A LOT NUMBER TRACEABLE TO MANUFACTURING RECORDS. ADD'L INFO WAS REQUESTED ON 01/31/2008 BY EMAIL. ADD'L INFO WAS RECEIVED FROM THE SURGEON ON 02/05/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED, HE EXPLANTED AN INTRAOCULAR LENS (IOL) TWO MONTHS FOLLOWING THE INITIAL IOL IMPLANT SURGERY DUE TO UNEXPECTED PT OUTCOME. THE SURGEON REPORTED, THE POSSIBLE CAUSE OF THE UNEXPECTED PT OUTCOME WAS DUE TO THE IOL ROTATING OFF AXIS OR WRONG LENS POWER. THE REPLACEMENT LENS WAS THE SAME LENS MODEL, BUT A DIFFERENT LENS DIOPTER. THE PT OUTCOME WAS REPORTED AS EXCELLENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60T5 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention