Optovue iVue Recall for Missing 510(k) on Vault Mapping Software
Optovue is recalling 326 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 explicitly states no illnesses or injuries were reported, and the hazard is a regulatory documentation issue (missing 510(k)) rather than a direct physical safety defect.
Plain-English summary
Optovue, Inc. is recalling 326 iVue with Normative Database devices. The iVue is a non-contact, high-resolution tomographic imaging device intended for in vivo imaging and measurement of anterior and posterior ocular structures, including the retina and optic disc.
The recall was initiated because the FDA determined that a 510(k) is needed for the Vault Mapping software, also known as Lens Fitting. The affected devices were distributed nationwide in 38 states, including Alabama, Arizona, California, Florida, New York, and Texas.
Consumers and healthcare providers should contact Optovue, Inc. for further instructions regarding the recall. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a 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 an
- 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 (12)
- Cat No. 700-45575 (GTIN - N/A)
- 700-45575-002 (GTIN - N/A)
- 700-45575-A (GTIN - N/A)
- 700-47818-001 (GTIN - N/A)
- 700-47818-002 (GTIN - N/A)
- 700-47818-003 (GTIN - N/A)
- 700-47818-004 (GTIN 00858848006056)
- 700-47827-002 (GTIN - N/A)
- 700-47827-004 (GTIN - N/A)
- 700-47827-005 (GTIN 00858848006070)
- 700-49007-002 (GTIN - N/A)
- 700-49007-003 (GTIN 00858848006216).
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 iFusion and iVue Recalled for Missing 510(k) Approval
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