BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR® INJECTOR

    MDR report key: 3885004 · Received June 19, 2014

    Report

    Report Number
    2023826-2014-00467
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 22, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    KYB
    PMA / PMN Number
    K954600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE INJECTOR WAS NOT RETURNED, HOWEVER THE LENS WAS RECEIVED AND EVALUATED. A HAPTIC WAS TORN OFF AND MISSING AND THERE WAS A DARK SURGICAL RESIDUE ON THE LENS. EVALUATION CODES CONCLUSION (UNABLE TO CONFIRM): BASED ON THE COMPLAINT HISTORY AND THE EVALUATION OF THE RETURNED PRODUCT, WE WERE UNABLE TO CONFIRM THIS COMPLAINT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT TWO AA4204VF SILICONE SINGLE PIECE LENSES WERE TORN BY THE INJECTOR AS THE SURGERY TECH ATTEMPTED TO PRIME THE LENS THROUGH THE INJECTION SYSTEM. THERE WAS NO PATIENT CONTACT. THE REPORTER STATED THEY REUSE THE INJECTOR LESS THAN RECOMMEND IN THE DFU, SUFFICIENT VISCOELASTIC WAS USED AND THE LENS WAS LOADED BY AN EXPERIENCED TECH. A NEW INJECTOR WAS USED AND THE THIRD LENS WAS SUCCESSFULLY IMPLANTED. THE CUSTOMER CONCLUDED THE EVENT WAS DUE TO A DEFECTIVE INJECTOR. SEE MFR REPORT #2023826-2014-00468 FOR OTHER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361682 MICROSTAAR® INJECTOR INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL COMPANY MSI-PR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR LENS MODEL AA4204VL, SERIAL (B)(4)| MTC-60CFP CARTRIDGE MODEL, LOT NUMBER UNKNOWN