The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0009-2018·Announced 2017-09-06

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.

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 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…
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. 700-49001-001 (GTIN - N/A)
  • 700-49001-003 (GTIN - N/A)
  • 700-49001-004 (GTIN 00858848006186).

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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