BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR CARTRIDGE

    MDR report key: 1618426 · Received February 23, 2010

    Report

    Report Number
    2023826-2010-00182
    Event Type
    Malfunction
    Date Received
    February 23, 2010
    Report Date
    February 16, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MSS
    PMA / PMN Number
    K980696
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (CARTRIDGE TIP NARROWER, BACK WIDER, THAN OTHER SIMILAR CARTRIDGES). EVAL, METHOD: CARTRIDGE LOT NUMBER SEARCH. RESULTS: A CARTRIDGE LOT NUMBER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND THE LOT NUMBER SEARCH, AN SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B) (4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON HAD TROUBLE LOADING A CC4204BF COLLAMER SINGLE PIECE LENS INTO AN SFC-25 FP CARTRIDGE. THE REPORTER STATED THE CARTRIDGE LOOKED DIFFERENT THAN THE OTHER SFC-25 FP CARTRIDGES, THE TIP WAS NARROWER AND THE BACK WAS WIDER. THE REPORTER STATED THEY CHANGED TO A DIFFERENT CARTRIDGE LOT NUMBER AND WERE ABLE TO IMPLANT THE LENS WITH NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR INJECTOR CARTRIDGE INTRAOCULAR LENS FOLDERS AND INJECTORS MSS STAAR SURGICAL CO. SFC-25 FP 1234924

    Patients

    Seq Age Sex Outcome Treatment
    1 FOAM TIP PLUNGER: MODEL AND LOT NUMBER UNK| INJECTOR: MODEL AND LOT NUMBER UNK| LENS: CC4204BF - SERIAL NUMBER UNK