The Recall Desk

Manufacturer

Optovue, Inc.

6 recalls in our database name Optovue, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2017-09-06

Of the 6 recalls from Optovue, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • ModerateFDA (Devices)·Z-0010-2018·2017-09-06

    Optovue iVue 500 Recalled for Missing 510(k) for Vault Mapping Software

    Optovue is recalling 326 iVue 500 devices because FDA determined a 510(k) is needed for the Vault Mapping software.

    Product
    iVue 500 with iScan, D216606. Product 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 and posterior ocular structures, including retina, retinal nerve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0009-2018·2017-09-06

    Optovue iFusion and iVue Recalled for Missing 510(k) Approval

    Optovue is recalling 326 iFusion and iVue devices because FDA determined a 510(k) is needed for the Vault Mapping software.

    Product
    iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0008-2018·2017-09-06

    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.

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1498-2016·2016-04-27

    Optovue iVue OCT Systems Recalled for Software Display Anomaly

    Optovue is recalling iVue and iVue 500 OCT systems due to a software anomaly that may display duplicate eye images instead of distinct right and left views.

    Product
    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 US) Opthalmic: iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensi
    Category
    Medical Device
    Distribution
    21 states
  • LowFDA (Devices)·Z-1441-2013·2013-06-12

    Optovue iVue Software Recall Due to Inconsistent Color Display

    Optovue, Inc. is recalling iVue software versions 3.0 and 3.1 because color displays for Ganglion Cell Complex thickness are inconsistent across different report types.

    Product
    Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0024-2013·2012-10-31

    Optovue Recalls Reference Materials Shipped with iVue and RTVue Systems

    Optovue is recalling 795 units of reference materials shipped with iVue and RTVue systems because they were not included in the FDA clearance.

    Product
    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by O
    Category
    Medical Device
    Distribution
    Distributed nationwide