Optovue iFusion Device Recall: Missing FDA Approval for Eye Imaging Software
Optovue recalls iFusion eye imaging devices due to missing FDA approval for Vault Mapping software. The recall affects specific model numbers sold for retinal imaging. Consumers should contact Optovue for details.
Recall notice
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Contact the company
What happened, in plain English
Optovue is recalling certain iFusion eye imaging devices because the Vault Mapping software (Lens Fitting) lacks required FDA approval. This means the software may not be safe for clinical use as intended. Read more at govinfonow.com/recall/73336-optovue-ifusion-device-recall-missing-fda-approval-for-eye-imaging.
Source Summary by GovInfoNow · govinfonow.com/recall/73336-optovue-ifusion-device-recall-missing-fda-approval-for-eye-imaging · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0009-2018
Cite this page
“Optovue iFusion Device Recall: Missing FDA Approval for Eye Imaging Software.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73336-optovue-ifusion-device-recall-missing-fda-approval-for-eye-imaging. Based on FDA recall #Z-0009-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0009-2018%22&limit=1).
Why it’s dangerous
The FDA requires approval for medical software before it can be used in clinical settings. Without this approval, the Vault Mapping software may not function safely or accurately during eye exams.
Who’s affected
Clinicians and patients using the iFusion eye imaging devices with the Vault Mapping software. Those who have the specific model numbers listed in the recall are most at risk.
How to tell if you have this one
Check for model numbers 700-49001-001, 700-49001-003, or 700-49001-004 on the device packaging or label. The iFusion devices are used for non-contact retinal imaging without eye dilation.
- Brand
Optovue- Product
iFusion, Device Listing Number D203271- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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.
| Recall number | Product, codes & lots |
|---|---|
| Z-0008-2018 | iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a 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 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 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.; Cat No. 700-45575 (GTIN - N/A), 700-45575-002 (GTIN - N/A), 700-45575-A (GTIN - N/A), 700-47818-001 (GTIN - N/A), 700-47818-002 (GTIN - N/A), 700-47818-003 (GTIN - N/A), 700-47818-004 (GTIN 00858848006056), 700-47827-002 (GTIN - N/A), 700-47827-004 (GTIN - N/A), 700-47827-005 (GTIN 00858848006070), 700-49007-002 (GTIN - N/A), 700-49007-003 (GTIN 00858848006216). |
| Z-0009-2018 | 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.; Cat No. 700-49001-001 (GTIN - N/A), 700-49001-003 (GTIN - N/A), 700-49001-004 (GTIN 00858848006186). |
| Z-0010-2018 | 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.; Cat No. 700-49428-001 (GTIN - N/A), 700-49428-002 (GTIN 00858848006315), 700-49428-003 (GTIN 00858848006018). |
What to do — step by step
Check Device Model
Look for model numbers 700-49001-001, 700-49001-003, or 700-49001-004 on the device packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 40 states.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 3.7 years after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0009-2018 (July 27, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0009-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.