Facility

OPTOVUE, INC.

4 recall(s) on record — most severe on record: Class II.

Key facts

4recalls · worst Class II

2inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3005950902
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198
Location	231 Charcot Avenue San Jose, CA, US 95131
Registration status	Active · expires 2026
Parent company	OPTOVUE, INC. (owner-operator 9091799)
Brand names	Avanti

Activity by year

Recalls (4)
Inspections (2)

Devices registered here (2)

Tomography, Optical Coherence
Product code OBO (opens in a new tab) · Class II · Ophthalmic · 21 CFR 886.1570
Ophthalmoscope, Ac-Powered
Product code HLI (opens in a new tab) · Class II · Ophthalmic · 21 CFR 886.1570

Recalls & enforcement

Class IITerminated2017-07-27
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Class IITerminated2016-03-16
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.
Class IIITerminated2013-05-14
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.
Class IITerminated2012-09-07
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) clear…

FDA inspections (2)

NAI2017-03-20
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2016-04-14
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by OPTOVUE, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “OPTOVUE, INC. (FEI 3005950902) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005950902-optovue-inc/

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