Optovue iFusion and iVue Recalled for Missing 510(k) Approval
Optovue is recalling 326 iFusion and iVue devices because FDA determined a 510(k) is needed for the Vault Mapping software.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a regulatory documentation deficiency (missing 510(k)) rather than a direct safety hazard or reported injury, aligning with the 'Moderate' criteria for minor labeling/documentation errors.
Plain-English summary
Optovue, Inc. is recalling 326 units of the iFusion and iVue devices. These are non-contact digital imaging and optical coherence tomography systems used to photograph and measure ocular structures. The recall was initiated because the FDA determined that a 510(k) is needed for the Vault Mapping software, also known as Lens Fitting, which is part of the device functionality.
The affected devices were distributed nationwide in the United States, including in Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, and West Virginia.
Consumers and healthcare providers should stop using the Vault Mapping software feature. Optovue is the recalling firm responsible for addressing the regulatory deficiency. No specific instructions for returning the devices are provided in the source text.
The recalled product
- 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 conditio
- Manufacturer
- Optovue, Inc.
- Affected units
- 326
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Cat No. 700-49001-001 (GTIN - N/A)
- 700-49001-003 (GTIN - N/A)
- 700-49001-004 (GTIN 00858848006186).
Distribution
Part of a larger recall action
This product is one of 3 recalled by Optovue, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Optovue, Inc.
See all →- ModerateOptovue iVue 500 Recalled for Missing 510(k) for Vault Mapping Software
FDA (Devices) · 2017-09-06
- ModerateOptovue iVue Recall for Missing 510(k) on Vault Mapping Software
FDA (Devices) · 2017-09-06
- ModerateOptovue iVue OCT Systems Recalled for Software Display Anomaly
FDA (Devices) · 2016-04-27
- LowOptovue iVue Software Recall Due to Inconsistent Color Display
FDA (Devices) · 2013-06-12
- ModerateOptovue Recalls Reference Materials Shipped with iVue and RTVue Systems
FDA (Devices) · 2012-10-31
Same hazard · regulatory non compliance
See all →- ModerateMedline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01