BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTAAR® INJECTOR

    MDR report key: 2834435 · Received November 15, 2012

    Report

    Report Number
    2023826-2012-00919
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 19, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MSS
    PMA / PMN Number
    K980696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, METHOD: CARTRIDGE LOT NUMBER SEARCH. RESULTS: A CARTRIDGE LOT NUMBER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE LOT. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE CARTRIDGE LOADING AREA NARROW. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, LOT NUMBER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION:METHOD - DEVICE HISTORY RECORD REVIEW.RESULTS - A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NOTHING WAS FOUND IN THE MANUFACTURING PROCESS OF THIS PRODUCT THAT WAS THE ROOT CAUSE OF THE COMPLAINT.CONCLUSIONS - BASED ON THE COMPLAINT HISTORY, LOT NUMBER SEARCH, DEVICE HISTORY RECORD REVIEW AND THE EVALUATION OF THE RETURNED PRODUCT, THE MOST LIKELY ROOT CAUSE OF THE EVENT IS DUE TO STORAGE CONDITIONS OR HANDLING AT THE CUSTOMER FACILITY.(B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THEY RECEIVED AN ABNORMAL SFC-45 FP CARTRIDGE, LOT NUMBER 1270057. THE CARTRIDGE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSTAAR® INJECTOR INTRAOCULAR LENS MSS STAAR SURGICAL COMPANY SFC-45 FP 1270057

    Patients

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