Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77776

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 27, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Optovue, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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 and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.

Z-0008-2018
Recall number
Z-0008-2018
Initiated
July 27, 2017
Classification
Class II
Status
Terminated
Recalling firm
Optovue, Inc.
Quantity
326 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Cat No. 700-45575 (GTIN - N/A), 700-45575-002 (GTIN - N/A), 700-45575-A (GTIN - N/A), 700-47818-001 (GTIN - N/A), 700-47818-002 (GTIN - N/A), 700-47818-003 (GTIN - N/A), 700-47818-004 (GTIN 00858848006056), 700-47827-002 (GTIN - N/A), 700-47827-004 (GTIN - N/A), 700-47827-005 (GTIN 00858848006070), 700-49007-002 (GTIN - N/A), 700-49007-003 (GTIN 00858848006216).

Distribution pattern

US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, & WV.

device · product 2 of 3

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 conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior. ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects.

Z-0009-2018
Recall number
Z-0009-2018
Initiated
July 27, 2017
Classification
Class II
Status
Terminated
Recalling firm
Optovue, Inc.
Quantity
326 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Cat No. 700-49001-001 (GTIN - N/A), 700-49001-003 (GTIN - N/A), 700-49001-004 (GTIN 00858848006186).

Distribution pattern

US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, & WV.

device · product 3 of 3

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 fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.

Z-0010-2018
Recall number
Z-0010-2018
Initiated
July 27, 2017
Classification
Class II
Status
Terminated
Recalling firm
Optovue, Inc.
Quantity
326 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Cat No. 700-49428-001 (GTIN - N/A), 700-49428-002 (GTIN 00858848006315), 700-49428-003 (GTIN 00858848006018).

Distribution pattern

US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, & WV.