BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR CARTRIDGE

    MDR report key: 1000701 · Received February 21, 2008

    Report

    Report Number
    2023826-2008-00228
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    December 18, 2007
    Report Date
    January 24, 2008
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    KYB
    PMA / PMN Number
    K+954600
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: A LOT NUMBER SEARCH. RESULTS A CARTRIDGE AND FOAM TIP PLUNGER LOT NUMBER SEARCH WAS PERFORMED FOR SIMILAR COMPLAINTS WITHIN THE SEARCH AND THERE WERE NO SIMILAR COMPLAINTS FOUND.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON WAS ADVANCING A EYEONIC CRYSTALENS MODEL LENS IN A MTC -60CFP CARTRIDGE AND FOAM TIP PLUNGER AND THE TIP OF THE PLUNGER PUSHED AGAINST THE LENS AND BROKE THE LENS AND A HAPTIC. LENS WAS REMOVED AND REPLACED WITH A SECOND CRYSTALENS WITH 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 1233158

    Patients

    Seq Age Sex Outcome Treatment
    1 FOAM TIP PLUNGER: FTP| INJECTOR MODEL: UNK