The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0010-2018·Announced 2017-09-06

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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.
Category
Medical Device — Ophthalmic Imaging
Hazard
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

Distributed nationwide across the United States.

The notice also names 40 states specifically:

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 →

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