BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR FOAM TIP PLUNGER

    MDR report key: 1061029 · Received June 13, 2008

    Report

    Report Number
    2023826-2008-00817
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 30, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    MSS
    PMA / PMN Number
    K980696
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS - A VISUAL INSPECTION OF THE RETURNED PRODUCTS SHOWS THE FOAM TIP ON THE PLUNGER IS BROKEN, ONE HAPTIC IS TORN OFF OF THE LENS AND THE OPTIC IS TORN IN HALF. THE CARTRIDGE HAS NO VISIBLE DAMAGE. THE CARTRIDGE AND LENS HAS CLEAR SURGICAL RESIDUE ON THEM. IT SHOULD BE NOTED THAT THE INJECTOR WAS NOT RECEIVED FOR INSPECTION. 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) HAS 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 AS THE SURGEON WAS INSERTING A +24.0 DIOPTER ONE PIECE COLLAMER LENS USING THE FTP INDIGO IN THE INDIGO-P INJECTOR AND THE PLUNGER ROD BENT AND TORE THE LENS. THE SURGEON CUT THE LENS TO REMOVE IT AND PUT IN ANOTHER SAME TYPE LENS, NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR FOAM TIP PLUNGER INTRAOCULAR LENS FOLDERS AND INJECTORS MSS STAAR SURGICAL FTP-INDIGO 1233322

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE: MODEL SFC25FP LOT#1235958| LENS: MODEL CC4204BF| INJECTOR: MODEL INDIGO-P LOT#UNK