BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR® INJECTOR

    MDR report key: 2832622 · Received November 14, 2012

    Report

    Report Number
    2023826-2012-00908
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    September 18, 2012
    Report Date
    October 17, 2012
    Product Code
    KYB
    PMA / PMN Number
    K954600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER PROVIDED THE FOLLOWING; SINCE OUR CONVERSATION LAST MONTH THEIR FACILITY CONCLUDED THE EVENT WAS DUE TO A LOADING ISSUES. STAAR REP HAD PERFORMED AN INSERVICE FOR THE NEWER SURGICAL TECH AND THE LENS TEARS HAS DECREASE SIGNIFICANTLY. THE CARTRIDGE WAS NOT RETURNED, HOWEVER, THE LENS WAS RECEIVED AND EVALUATED. BOTH THE HAPTICS AND THE OPTIC WERE SPLIT AND THERE WAS A CLEAR SURGICAL RESIDUE ON THE LENS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, CONCLUSION: AN INVESTIGATION OF THE ROOT CAUSES OF LENS TEARS, SIMILAR TO THAT STATED IN THIS CLAIM, WERE ADDRESSED IN A CAPA OPENED, WHICH WAS SUBSEQUENTLY CLOSED. THE CAPA ADDRESSED DELIVERY SYSTEM ISSUES INCLUDING ALL STAGES OF MANUFACTURING OF THE INJECTORS AND CARTRIDGES. PROCESSES WERE REVIEWED AND REVISED AS OPPORTUNITIES FOR IMPROVEMENT WERE REVEALED. THE CAPA ALSO ADDRESSED 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. BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, POSSIBLE ROOT CAUSES FOR LENS TEARS INCLUDE BOTH DELIVERY SYSTEM ISSUES AND HANDLING ERRORS BY THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLUE TIP DID NOT COME OUT OF THE CARTRIDGE ONTO THE TIP OF THE LENS INJECTOR AND AS THE SURGEON INSERTED THE AA4203TL SILICONE SINGLE PIECE LENS, THE CARTRIDGE TORE THE LENS. THERE WAS NO PATIENT INJURY. THE REPORTER INDICATED THERE WERE LOADING ISSUES AND THE CARTRIDGE WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR® INJECTOR INTRAOCULAR LENS GUIDE KYB MTC-60CFP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR LENS MODEL AA4203TL, SERIAL# (B)(4)| INJECTOR MODEL MSI-PR, LOT NUMBER UNKNOWN