BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMICROSTAAR FOAM TIP PLUNGER

    MDR report key: 1083160 · Received July 29, 2008

    Report

    Report Number
    2023826-2008-00998
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 1, 2008
    Manufacturer
    STAAR SURGICAL
    Product Code
    MSS
    PMA / PMN Number
    K073591
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT NUMBER SEARCH WAS PERFORMED FOR THE CARTRIDGE, INJECTOR, FOAM TIP PLUNGER AND LENS FOR SIMILAR COMPLAINTS WITHIN THE SEARCH AND THERR WERE TWO SIMILAR COMPLAINTS FOUND FOR THE CARTRIDGE, ONE SIMILAR COMPLAINT FOR THE INJECTOR, NO SIMILAR COMPLAINTS FOR THE FOAM TIP PLUNGER AND FIVE SIMILAR COMPLAINTS FOR THE LENS OF WHICH ALL WERE USED WITH A DIFFERENT INJECTION SYSTEM.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SURGEON WAS INSERTING A 21.0 DIOPTER ASPHERIC COLLAMER LENS USING A FOAM TIP PLUNGER AND THE LENS FLIPPED UPON INSERTION AND A HAPTIC BECAME BENT. THE SURGEON WAS ABLE TO TURN THE LENS OVER IN THE EYE AND THERE WAS NO PERMANENT DAMAGE TO THE LENS OR HAPTIC, SO THE SURGEON DECIDED TO LEAVE THE LENS IN THE EYE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAMICROSTAAR FOAM TIP PLUNGER INTRAOCULAR LENS FOLDERS AND INJECTORS MSS STAAR SURGICAL FTP GREEN 1238186

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR RTRIDGE MODEL: CQ-G CARTRIDGE FP LOT NUMB: 1239008| LENS MODEL: CQ2015A| INJECTOR: MSI-FP-G LOT NUMBER: 1239168