Optovue iVue 500 Recalled for Missing 510(k) for Vault Mapping Software
Optovue is recalling 326 iVue 500 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 requirement (missing 510(k)) rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity voluntary precautionary or documentation-related recall.
Plain-English summary
Optovue, Inc. is recalling 326 units of the iVue 500 with iScan (D216606) non-contact, high-resolution tomographic imaging device. The recall is due to FDA determining that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
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.
The iVue 500 is intended for in vivo imaging and measurement of anterior and posterior ocular structures. Users should contact Optovue, Inc. for further instructions regarding the recall.
The recalled product
- 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
- 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. 700-49428-001 (GTIN - N/A)
- 700-49428-002 (GTIN 00858848006315)
- 700-49428-003 (GTIN 00858848006018).
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
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