BEUDAMED
    FDA Recall Terminated

    SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses.

    Recall: Z-2711-2016 · Initiated August 8, 2016

    Recall

    Recall Number
    Z-2711-2016
    Event Number
    74900
    Firm
    Nidek Inc
    FEI Number
    2936921
    Product Code
    NQE
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    August 8, 2016
    Posted
    September 1, 2016
    Terminated
    January 9, 2017
    Address
    47651 Westinghouse Dr, Fremont, CA, 94539-7474

    Description

    SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses.

    Reason

    Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed and approved by the FDA.

    Action

    The firm, Nidek, sent a Dear Doctor letters entitled "RECALL NOTIFICATION" dated August 15, 2016 to affected sites by Federal Express. The letter informs users of the issue and stated that Nidek field service representatives will visit to install updated software. If you have any questions, please call Customer Service at 1-800-722-0219; Monday-Friday 8am to 5pm PST or email: [email protected].

    Distribution

    US Distribution to states of: TX, KS, FL, NV, CA, PA, KY, OR, TN, AL, VA, MO, OK, CT, NY. LA, NM, and IN.

    Quantity

    29 affected devices