# FDA recall Z-0010-2018

> **Optovue, Inc.** · Class II · device recall initiated 2017-07-27.

## 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 for recall

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

## 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.

## Key facts

- **Recall number:** Z-0010-2018
- **Recalling firm:** Optovue, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-27
- **Report date:** 2017-09-06
- **Termination date:** 2021-04-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fremont, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0010-2018

## Citation

> AI Analytics. FDA recall Z-0010-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0010-2018. Source: US FDA. Licensed CC0.

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