BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 3093796 · Received April 30, 2013

    Report

    Report Number
    1119421-2013-00459
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS NOT RETURNED IN THE CARTON. THE LABEL SET AND A SMALL EMPTY PLASTIC TRAY WERE RETURNED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE WERE NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE ROOT CAUSE MAY BE RELATED TO A FAILURE TO FOLLOW THE DFU. THE FILE INDICATES THE USE OF AN UNAPPROVED VISCOELASTIC WITH THE LENS/CARTRIDGE COMBINATION. DUE TO VARYING VISCOSITY, THE USE OF UNAPPROVED VISCOELASTICS MAY RESULT IN LENS DELIVERY DIFFICULTIES OR PRODUCT DAMAGE. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE SURGEON NOTED THE HAPTIC WAS BROKEN. THE INCISION HAD TO BE EXTENDED TO REMOVE THE LENS AND A REPLACEMENT LENS WAS USED TO COMPLETE THE SURGERY. THE WOUND WAS SUTURED. THERE WAS A DELAY OF ABOUT 20 MINUTES AND IT WAS UNK IF THE PT HAD ANY IMPACT. THE REPORTER INDICATED THE USE OF AN UNAPPROVED VISCOELASTIC. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186672 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/ HUNTINGTON SN6A77 11071072

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention OZIL HANDPIECE| MONARCH CARTRIDGE| HEALON