BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH II IOL DELIVERY SYSTEM CARTRIDGE - B

    MDR report key: 1210087 · Received October 22, 2008

    Report

    Report Number
    1119421-2008-00824
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    May 15, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    KYB
    PMA / PMN Number
    K001157
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS. BOTH HAPTICS WERE TUCKED IN ON THE ANTERIOR OPTIC SURFACE. THE HAPTICS DID NOT APPEAR TO HAVE ANY BROKEN AREAS. THE TIP OF THE NOZZLE IS STRESSED-REJECTABLE. THE OBSERVATIONS NOTED REASONABLY SUGGEST THAT THE DAMAGE WAS CLOSELY RELATED TO NON-ADHERENCE TO THE DIRECTION FOR USE. THE DAMAGE CAN OCCUR WHEN AN INSUFFICIENT QUANTITY OF LUBRICATING SOLUTION IS PRESENT BETWEEN THE LENS AND THE CARTRIDGE LUMEN (WALL) OR WHEN THE LENS IS NOT POSITIONED CORRECTLY IN THE CARTRIDGE. EVALUATION ALSO OBSERVED A LACK OF LUBRICATING SOLUTION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED FOR THE DEVICE BECAUSE THE FACILITY DID NOT PROVIDE A LOT NUMBER OF ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED ON 09/24/2008 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 09/25/2008. THIS REPORT WAS MAILED TO FDA ON: 10/22/2008.

    Description of Event or Problem · 1

    A PURCHASING AGENT REPORTED A BROKEN HAPTIC ON AN INTRAOCULAR LENS (IOL) AND A CAPSULAR BAG TEAR. IN A FOLLOW-UP, THE SURGEON STATED THAT THE IOL WAS REMOVED AND A MINIMAL VITRECTOMY WAS PERFORMED. ALSO, HE REPORTED THAT THE PROGNOSIS FOR THE PATIENT AS "EXCELLENT". IN THE SURGEON'S OPINION, THE DEVICE DID CAUSE/CONTRIBUTE TO THE EVENT BUT HE IS UNSURE WHETHER MALROTATION OF THE LENS IN THE CARTRIDGE OR THE LOADING METHOD IS THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARCH II IOL DELIVERY SYSTEM CARTRIDGE - B LENS GUIDE KYB ALCON RESEARCH, LTD./HUNTINGTON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other HEALON - GV