The Recall Desk

FDA (Devices) recall action 77776

Optovue, Inc. recalled 3 products on 2017-09-06

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2017-09-06
Critical
0
Units
978

Why these products were recalled

FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··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
    Distribution
    40 states
  • ModerateFDA (Devices)··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
    Distribution
    40 states
  • ModerateFDA (Devices)··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
    Distribution
    40 states