BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 1338662 · Received March 6, 2009

    Report

    Report Number
    2023826-2009-00203
    Event Type
    Malfunction
    Date Received
    March 6, 2009
    Date of Event
    January 15, 2009
    Report Date
    February 6, 2009
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    KYB
    PMA / PMN Number
    K954600
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: (OTHER) - AN INVESTIGATION WAS OPENED TO EVALUATE A COMPLAINT TREND ASSOCIATED WITH LENS TEARS THAT WAS ORIGINALLY IDENTIFIED IN JUNE 2005. POSSIBLE ROOT CAUSE FOR LENS TEARS INCLUDE BOTH DELIVERY SYSTEM ISSUES AND POSSIBLE HANDLING ERRORS BY THE CUSTOMER. TO ADDRESS DELIVERY SYSTEM ISSUES, ALL STAGES IN THE MANUFACTURING OF THE INJECTORS AND CARTRIDGES WERE REVIEWED AND REVISED AS OPPORTUNITIES FOR IMPROVEMENT WERE REVEALED. TO ADDRESS HANDLING ERRORS, ALL INJECTOR/CARTRIDGE DIRECTIONS FOR USE (DFU) HAVE BEEN MODIFIED TO ADD FURTHER CLARIFICATIONS TO INSTRUCT THE USERS IN THE PROPER DELIVERY TECHNIQUES THAT ARE EFFECTIVE, AND MINIMIZE THE POTENTIAL FOR DAMAGING THE LENS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED AN AA4204VL SILICONE SINGLE PIECE LENS AND THE PLUNGER OF THE INJECTOR CAUGHT AND TORE THE TRAILING HAPTIC UPON INSERTION. THE INCISION WAS ENLARGED TO REMOVE THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL CO. MSI-PM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention LENS: MODEL AA4204VL| CARTRIDGE: MODEL AQ CARTRIDGE-FP