BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR INJECTOR

    MDR report key: 3021045 · Received March 20, 2013

    Report

    Report Number
    2023826-2013-00214
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 18, 2013
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    K073586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT PERTAINING TO THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LENS WAS RETURNED AND VISUAL INSPECTION FOUND HALF OF PLATE HAPTIC IS TORN OFF AND MISSING. LENS WAS RETURNED IN LIQUID. METHOD - LENS WORK ORDER SEARCH. LOT NUMBER SEARCH. RESULT - A LENS WORK ORDER AND LOT NUMBER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER AND LOT NUMBER. CONCLUSIONS - THE PRODUCT PERTAINING TO THIS CLAIM WAS NOT RETURNED FOR EVALUATION. BASED ON THE COMPLAINT HISTORY, LENS WORK ORDER AND CARTRIDGE LOT NUMBER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE TECH USED A 23.5 DIOPTER CC4204A COLLAMER SINGLE PIECE LENS. THE SURGICAL TECH LOADED THE LENS INTO THE CARTRIDGE AND THEN ONTO THE INJECTOR. THE TECH FELT A TIGHT FIT IN THE CARTRIDGE. THE DOCTOR DECIDED NOT TO USE THE LENS AND REQUESTED ANOTHER LENS AND CARTRIDGE. THE REPORTER ADDED THAT THEY CONTINUED TO USE CARTRIDGES FROM THE SAME LOT NUMBER AND THEY DID NOT HAVE ANY FURTHER PROBLEMS. THE LENS WAS DAMAGED WHEN IT WAS REMOVED FROM THE CARTRIDGE. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115644 MICROSTAAR INJECTOR INTRAOCULAR LENS FOLDERS AND INJECTORS MTA STAAR SURGICAL CO. SFC-25 FP 1265758

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR MODEL AND LOT NUMBER - UNK| LENS MODEL CC4204A - SERIAL NUMBER - (B)(4)