BEUDAMED
    FDA Recall Terminated

    iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic: iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber the eye.

    Recall: Z-1498-2016 · Initiated March 16, 2016

    Recall

    Recall Number
    Z-1498-2016
    Event Number
    73612
    Firm
    Optovue, Inc.
    FEI Number
    3005950902
    Product Code
    HLI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 16, 2016
    Terminated
    April 4, 2017
    Address
    2800 Bayview Dr, Fremont, CA, 94538-6518

    Description

    iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic: iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber the eye.

    Reason

    A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database that may display images of the same eye rather than right and left if user scrolls on the map.

    Action

    Recall Letters were sent to customers on March 22, 2016 to inform them of the recall.

    Distribution

    PA, CA, IL, HI. MO, CO, GA, ME, IN, AZ, WV, VA, FL, AR, UT, NE, IN, NV, LA, TN, KS, OK. Foreign distribution forthcoming

    Quantity

    40