BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR CARTRIDGE

    MDR report key: 1061022 · Received June 13, 2008

    Report

    Report Number
    2023826-2008-00811
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 23, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    KYB
    PMA / PMN Number
    K954600
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS - A VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWS THE LENS HAS A HAPTIC TORN OFF AND IS STUCK IN THE CARTRIDGE. THERE IS NO VISIBLE DAMAGE TO THE CARTRIDGE. THERE IS CLEAR SURGICAL RESIDUE ON THE LENS AND CARTRIDGE. IT SHOULD BE NOTED THAT THE INJECTOR WAS NOT RETURNED FOR EVAL. CONCLUSIONS - AN INVESTIGATION WAS OPENED TO EVALUATE A COMPLAINT TREND ASSOCIATED WITH LENS TEARS THAT WAS ORIGINALLY IDENTIFIED IN JUNE 2005. POSSIBLE ROOT CAUSES 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

    THE REPORTER STATED THAT THE SURGEON WAS ADVANCING A 21.0 DIOPTER THREE PIECE SILICONE LENS IN AN AQ CARTRIDGE AND THE LENS TORE DUE TO THE CARTRIDGE WAS TOO STICKY AND WAS NOT LETTING THE LENS ADVANCE SMOOTHLY. NO PT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR CARTRIDGE INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL AQCARTRIDGE-FP 1235067

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR: MODEL MSI-PM LOT#UNK| LENS: MODEL AQ2010V| VISCOELAASTIC STAARVISC II: LOT#UNK