BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 838299 · Received February 21, 2007

    Report

    Report Number
    2023826-2007-00280
    Event Type
    Malfunction
    Date Received
    February 21, 2007
    Date of Event
    December 18, 2006
    Report Date
    January 22, 2007
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    KYB
    PMA / PMN Number
    p880091
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INJECTOR WAS NOT RETURNED FOR EVALUATION HOWEVER, THE LENS AND CARTRIDGE WERE RECEIVED AND A VISULA INSPECTION SHOWS THE LENS IS INSIDE THE CARTRIDGE. THERE IS NO VISIBLE DAMAGE TO THE CARTRIDGE. THERE IS CLEAR SURGICAL RESIDUE ON THE CARTRIDGE. CONCLUSION: BASED ON THE COMPLAINT HISTORY AND EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT, THE SURGEON WAS ADVANCING A 11.0 SE/3.5 SINGLE PIECE TORIC LENS WITH THE INJECTOR AND THE INJECTOR'S PLUNGER OVER-RODE THE LENS AND TORE THE LENS. THIS WAS ONE OF TWO INCIDENTS THAT OCCURRED TO THIS PATIENT. SEE MANUFACTURER REPORT 2033826-2007-00281 FOR THE OTHER REPORT. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL CO. MSI-TR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR CARTRIDGE MODEL: MTC-60CFP LOT NUMBER: UNK| LENS MODEL: AA4203TL