BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR CARTRIDGE

    MDR report key: 1022257 · Received March 26, 2008

    Report

    Report Number
    2023826-2008-00449
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    January 3, 2008
    Report Date
    March 5, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    KYB
    PMA / PMN Number
    K954600
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CARTRIDGE LOT NUMBER SEARCH WAS PERFORMED FOR SIMILAR COMPLAINTS WITHIN THE SEARCH AND THERE WERE THREE SIMILAR COMPLAINTS. AN INJECTOR LOT NUMBER SEARCH WAS PERFORMED FOR SIMILAR COMPLAINTS, AND NO SIMILAR COMPLAINTS WERE FOUND.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON WAS INSERTING A EYEONICS CRYSTALENS USING A MSI-PF INJECTOR AND A MTC- 60CFP CARTRIDGE AND THE LENS TORE ON HALF DURING INSERTION. THE REPORTER STATED THAT THE TRAILING HAPTIC GOT CAUGHT IN THE PLUNGER. THE SURGEON REMOVED THE LENS WITHOUT ENLARGING THE INCISION AND PUT IN A SECOND CRYSTALENS. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR CARTRIDGE INTRAOCULAR LENS GUIDE KYB STAAR SURGICAL CO. MTC 60CFP 1225669

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR INJECTOR MODE: MSI-PF