Recalls · Brand

Optovue, Inc. recalls

Every recall we track for Optovue, Inc. — 3 in all, all from 2017 — plus the complaints and injury reports the public filed about them.

3recalls

Recalls per year, by danger level

Recalls from Optovue, Inc. peaked in 2017 (3); 3 since 2017.

All FDA recall records for Optovue, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.

Recalls per year for Optovue, Inc., by danger level
Year	Lower risk	Not yet rated	Total
2017	1	2	3
2018	0	0	0
2019	0	0	0
2020	0	0	0
2021	0	0	0
2022	0	0	0
2023	0	0	0
2024	0	0	0
2025	0	0	0
2026 (to date)	0	0	0

What to do if you have a recalled Optovue, Inc. product

Match the model, catalog or lot number on your device to the recall.
Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
Report problems to FDA MedWatch.

See this week’s new recalls.

All Optovue, Inc. recalls

1 shown

UnratedMedical device
Optovue, Inc. recalls iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging
Optovue recalls iFusion eye imaging devices due to missing FDA approval for Vault Mapping software. The recall affects specific model numbers sold for retinal imaging. Consumers should contact Optovue for details.
OptovueJul 27, 2017

Optovue, Inc. recall questions

How many recalls has Optovue, Inc. had?

3 recalls from Optovue, Inc. are on record with U.S. safety agencies, from 2017.

What is the most recent Optovue, Inc. recall?

Optovue, Inc. recalls iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging, dated Jul 27, 2017. Every Optovue, Inc. recall is listed on this page, newest first.

What should I do if I have a recalled Optovue, Inc. product?

Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.

How do I get alerts for new Optovue, Inc. recalls?

Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.