BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF TORIC

    MDR report key: 1220385 · Received October 31, 2008

    Report

    Report Number
    1119421-2008-00860
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 25, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND SHOWED SIGNS OF HANDLING. THE OPTIC HAD LOOSE PARTICULATE-REJECTABLE AND LIGHT SCRATCHES-ACCEPTABLE. THE OPTIC ALSO HAD AN IMBED-REJECTABLE LOCATED NEAR THE OPTIC CENTER. WHILE WE WERE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATIONS REASONABLY SUGGEST THE DAMAGE IS NOT MANUFACTURING RELATED. IN ADDITION, THE MICRO MARKS OBSERVED WHEN USING ALTERNATE MICROSCOPIC INSPECTION METHODS HAVE PREVIOUSLY BEEN INVESTIGATED AND DO NOT HAVE ANY NEGATIVE EFFECT ON VISUAL ACUITY. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER.

    Description of Event or Problem · 1

    A SURGEON REPORTED SEEING A SCRATCH ON AN INTRAOCULAR LENS (IOL) PRIOR TO IMPLANTATION. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOUCLAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60T4 10802028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA