Optovue Recalls
6 recalls on record · October 31, 2012 to September 6, 2017 · Medical Devices
Recalls by year
12
13
16
17
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 6, 2017Medical DevicesFDA
Optovue, Inc. recalls iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in
Hazard: FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
September 6, 2017Medical DevicesFDA
Optovue, Inc. recalls iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging de
Hazard: FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
September 6, 2017Medical DevicesFDA
Optovue, Inc. recalls iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, hig
Hazard: FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
April 27, 2016Medical DevicesFDA
Optovue, Inc. recalls iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of
Hazard: A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database that may display images of the same eye rather than right and left if user scrolls on the map.
June 12, 2013Medical DevicesFDA
Optovue, Inc. recalls Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Hazard: 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.
October 31, 2012Medical DevicesFDA
Optovue Inc. recalls Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina
Hazard: Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and Interpretation Method" by Bruno Lumbroso and Marco Rispoli which are not labeled within 51O(k) cleared product description.