RegWardenFDA facility compliance records
Company

OPTOVUE, INC.

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

Recalls by year

FDA actions on record by year2012: 1 recalls; 2013: 1 recalls; 2016: 1 recalls; 2017: 1 recalls1’121’13’14’151’161’17’18’19’20’21’22’23’24’25’26
  • Recalls (4)

Registered facilities (1)

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…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “OPTOVUE, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9091799-optovue-inc/

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