Z-0010-2018Class II

iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended...

Name: Z-0010-2018 iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended...
Creator: Optovue, Inc.
Published: 2017-07-27
License: https://open.fda.gov/license/

Optovue Inc. / initiated 2017-07-27 / Terminated / root cause: software

FDA source

Optovue, Inc. began a recall of iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and... on 2017-07-27. FDA classified it as Class II and gives the reason as "FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0010-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-27
Posted: 2017-10-04
Terminated: 2021-04-12
Recalling firm: Optovue Inc.
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.
Product code: HLI Ophthalmoscope, Ac-Powered
Reason for recall: FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Root cause tag: software
FDA root cause: Other
Action: Optovue sent an Urgent Medical Device Software Field Correction letter dated July 27, 2017, via FedEx mail. Customers were Instructed to discontinue use of the Vault Mapping software, to complete and return the recall response form, and to provide remote access to units to an Optovue representative so that new software can be downloaded remotely. Questions can be addressed by calling Optovue at 1-866-941-9240.
Quantity in commerce: 326 devices
Distribution: US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, & WV.
Product codes and lots: Cat No. 700-49428-001 (GTIN - N/A), 700-49428-002 (GTIN 00858848006315), 700-49428-003 (GTIN 00858848006018).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0010-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0008-2018	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-10-04
Z-0009-2018	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-10-04
Z-0010-2018	Class II	Terminated	Voluntary: Firm initiated	2017-09-06	2017-10-04

Product code HLI

K133892Class IIIvue 500Optovue, Inc. / cleared 2014-03-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)