Optovue iVue Software Recall Due to Inconsistent Color Display
Optovue, Inc. is recalling iVue software versions 3.0 and 3.1 because color displays for Ganglion Cell Complex thickness are inconsistent across different report types.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or cosmetic issues.
Plain-English summary
Optovue, Inc. is recalling the Optovue iVue with Normative Database (NDB) software, specifically versions 3.0 and 3.1. The recall is due to a software defect where the colors used for Ganglion Cell Complex thickness in the singular OU report differ from those used in the individual iWellness ID and OS reports.
The affected software was distributed nationwide in the United States and in Canada. Approximately 329 users are affected by this recall. Version 3.1 is the international version, which was distributed to Canada but is not currently installed in any Canadian facilities.
Consumers and healthcare providers should contact Optovue, Inc. for further instructions regarding the software update or replacement. The recall is classified as Class III by the FDA, indicating that use of the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
- Manufacturer
- Optovue, Inc.
- Hazard
- Affected units
- 329
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 (1)
- iVue software version 3.0 and 3.1 3.1 is international version
Distribution
Distributed nationwide across the United States.
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