Z-0009-2018Class II

iFusion, Device Listing Number D203271

Name: Z-0009-2018 iFusion, Device Listing Number D203271
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 iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing... 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-0009-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-27
Posted: 2017-10-04
Terminated: 2021-04-12
Recalling firm: Optovue Inc.
Product: iFusion, 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 digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, 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 with Normative Database is a quantitative tool for comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects.
Product code: HKI Camera, Ophthalmic, 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. 700-49001-001 (GTIN - N/A), 700-49001-003 (GTIN - N/A), 700-49001-004 (GTIN 00858848006186).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0009-2018
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 HKI

K130656Class IIIfusionOptovue, Inc. / cleared 2013-07-03

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)