FDAJuly 27, 2017device
iVue 500 with iScan, D216606. Product 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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
What to do
FDA enforcement status: Terminated
Brands named
optovue
UPCs
7004942800170049428002008588480063157004942800300858848006018
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAiVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) 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 st...2017-07-27
- FDAiFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes di...2017-07-27
- FDAiVue 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 mea...2016-03-16
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