BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR CARTRIDGE

    MDR report key: 1191565 · Received October 1, 2008

    Report

    Report Number
    2023826-2008-01252
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    June 30, 2008
    Report Date
    September 8, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MSS
    PMA / PMN Number
    K980696
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT PERTAINING TO THIS COMPLAINT WAS NOT RETURNED FOR EVAL. HOWEVER, THE LENS WAS RETURNED FOR EVAL AND VISUAL INSPECTION FOUND THE LENS OPTIC AND ONE HAPTIC TORN, WITH A PIECE TORN OFF AND MISSING. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. IT SHOULD BE NOTED THAT THE INJECTOR AND FOAM TIP PLUNGER WERE NOT RETURNED FOR EVAL. CONCLUSIONS:OTHER - AN INVESTIGATION WAS OPENED TO EVALUATE A COMPLAINT TREND ASSOCIATED WITH LENS TEARS THAT WAS ORIGINALLY IDENTIFIED IN JUNE 2005. THE DAMAGE TO THE LENS, AS OBSERVED AND PHOTOGRAPHED UPON THE RETURN OF THE LENS TO STAAR, CANNOT BE DEFINITIVELY AND EXCLUSIVELY CORRELATED TO A SPECIFIC ROOT CAUSE. 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 THE TECHNICIAN HAD PROBLEMS LOADING A +17.5 DIOPTER COLLAMER SINGLE PIECE LENS. THE LENS WAS PARTIALLY INSERTED AND REMOVED WITH NO PT INJURY. THE REPORTER STATED THEY FELT THERE WAS A PROBLEM WITH THE CARTRIDGE. ANOTHER SAME MODEL LENS WAS LOADED INTO A DIFFERENT LOT OF CARTRIDGE AND WAS IMPLANTED WITH NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR CARTRIDGE INTRAOCULAR LENS FOLDERS AND INJECTORS MSS STAAR SURGICAL CO. SFC-25 FP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR LENS MODEL CC4204BF| FOAM TIP PLUNGER FTP INDIGO - LOT NUMBER UNK| INJECTOR MODEL INDIGO-P - LOT NUMBER UNK