BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH III IOL DELIVERY SYSTEM CARTRIDGE - D

    MDR report key: 1021197 · Received March 28, 2008

    Report

    Report Number
    1119421-2008-00197
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 22, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    KYB
    PMA / PMN Number
    K063155
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CARTRIDGE WAS NOT RETURNED. TEN UNOPENED CARTRIDGES FOR THE COMPLAINT LOT WERE RETURNED. TWO CARTRIDGES WERE SELECTED AND EVALUATED. FUNCTIONAL TESTING WAS CONDUCTED WITH THE APPROVED LENS MODEL AND VISCOELASTIC. FUNCTIONAL TESTING WAS ACCEPTABLE. DYE STAIN SHOWED A PULLED AREA IN THE TIP OF ONE CARTRIDGE, BUT NO EXPULSION. THE SECOND CARTRIDGE SHOWED NO DISTURBANCE TO THE COATING. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEWS INDICATED THE PRODUCTS MET RELEASE CRITERIA. THE FACILITY INDICATES THEY SOAK THE CARTRIDGES IN BSS PRIOR TO USE. THIS IS NOT PER THE DIRECTIONS FOR USE (DFU). IT IS UNKNOWN IF THE CORRECT VISCOELASTIC WAS USED BY THE REPORTER. THERE ARE FIFTEEN COMPLAINT REPORTS FOR FOREIGN MATERIAL IN THIS LOT. SIX OF THE FIFTEEN REPORTS ARE FROM THIS SURGEON AND TWO OF THESE SIX WERE REPORTED AS TASS CASES. ADDITIONAL INFORMATION WAS REQUESTED ON 02/22/2008, 02/28/2008, 02/29/2008 BY PHONE AND ON 03/05/2008 BY FAX AND BY MAIL. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON. THIS EVENT MEETS TASS CRITERIA. THIS REPORT WAS MAILED TO FDA ON: 03/28/2008.

    Description of Event or Problem · 1

    A NURSE REPORTED, TWO PATIENTS EXPERIENCED INFLAMMATION, TASS WITH 3+ CELL FLARE. BOTH PATIENTS HAVE RECOVERED AND ARE DOING FINE. IT WAS REPORTED THE SURGEON NOTED A PASTY MATERIAL ENTERING BOTH PATIENTS' EYES DURING SURGERY. HE USED IRRIGATION AND ASPIRATION (I/A) TO REMOVE THE MATERIAL AT THAT TIME. HE REPORTED THAT PRIOR TO USE, HE HAD SOAKED THE CARTRIDGES, BUT HE DID NOT KNOW HOW LONG THEY HAD SOAKED. THIS IS ONE OF TWO REPORTS BEING FILED FOR THIS SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARCH III IOL DELIVERY SYSTEM CARTRIDGE - D LENS GUIDE KYB ALCON RESEARCH, LTD. / HUNTINGTON NA 173802

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention