Optovue iVue with Normative Database (NDB) with Software… recallZ-1441-2013 · Optovue, Inc. · initiated May 14, 2013
Class III Terminated All recalls posted in May 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Optovue, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports.
FDA root cause category: Software design
What the company is doing
Optovue sent a Field Correction Notice letter dated May 16, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
Recall details
- Recall number
- Z-1441-2013
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- May 14, 2013
- Posted by the FDA
- May 31, 2013
- Recalling firm
- Optovue, Inc.
- Quantity
- ~329 users
- Product code
- HLI
- FDA submissions
- K121739
- Distribution
- Distributed Nationwide and in Canada.
Product description
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Code information (models, lots, serial numbers)
iVue software version 3.0 and 3.1 3.1 is international version, only distributed to Canada but not currently installed in any Canadian facilities.
Other devices under the same FDA submission
3 devices cleared under K121739 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- iVue iVue 100-1Optovue, Inc. · Ophthalmoscope, Ac-Powered1 recall0 reports
- iVue iVue 100Optovue, Inc. · Ophthalmoscope, Ac-Powered1 recall0 reports
- iVue iVue 100-1Optovue, Inc. · Ophthalmoscope, Ac-Powered1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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