Recall Z-0010-2018— Optovue, Inc.

Name: FDA recall Z-0010-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-27

Class II · Terminated

Class II FDA medical device recall by Optovue, Inc., initiated 2017-07-27, terminated 2021-04-12. It names one FDA 510(k) clearance: K133892. Product: 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 cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.. Reason: FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting)..

Recalling firm: Optovue, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-07-27
Terminated: 2021-04-12
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K133892 — IVUE 500Optovue, Inc.·cleared 2014-03-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.

Reason for recall

FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).

Data sourced from openFDA. This site is unofficial and independent of the FDA.