Optovue recalls

Optovue has 6 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 6 Sep 2017. The most frequent reason is device malfunction.

Total recalls6since 2012

Last 12 months0reported

Class I00% of total

Ongoing0latest 6 Sep 2017

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 5 83%Class III 1 17%

Why optovue is recalled

Device Malfunction583%
Other Reasons117%

Product types

Imaging Equipment583%
Hip & Knee Implants117%

By year

2017350%
2016117%
2013117%
2012117%

All optovue recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
6 Sep 2017Device	CLASS II	iVue 500 with iScan, D216606 recalled by Optovue	Optovue	Device Malfunction	Nationwide
6 Sep 2017Device	CLASS II	iVue with Normative Database, Device Listing Number D185549 recalled	Optovue	Device Malfunction	Nationwide
6 Sep 2017Device	CLASS II	iFusion, Device Listing Number D203271 recalled by Optovue	Optovue	Device Malfunction	Nationwide
27 Apr 2016Device	CLASS II	iVue and iVue 500 (now called iScan) OCT systems recalled by Optovue	Optovue	Device Malfunction	21 states
12 Jun 2013Device	CLASS III	iVue with Normative Database (NDB) recalled by Optovue	Optovue	Device Malfunction	Nationwide
31 Oct 2012Device	CLASS II	Reference materials "Retinal OCT Analysis recalled by Optovue	Optovue	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.