Recall Z-0010-2018
Optovue, Inc. · initiated July 27, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Cat No. 700-49428-001 (GTIN - N/A), 700-49428-002 (GTIN 00858848006315), 700-49428-003 (GTIN 00858848006018).
Reason for recall
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0010-2018
- Initiated
- July 27, 2017
- Terminated
- April 12, 2021
- Product code
- HLI – Ophthalmoscope, Ac-Powered
- Quantity
- 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.
- Recalling firm
- Optovue, Inc., Fremont, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0008-2018 Class II | iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue…FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | 07/27/2017Terminated |
| Z-0009-2018 Class II | iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high…FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | 07/27/2017Terminated |