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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83298

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 20, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Opternative 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

1 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 1

The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software application that partners and their customers were given access to. Product Usage: This online portion of the Visibly Vision Test Solution is used to measure vision refraction.

Z-2223-2019
Recall number
Z-2223-2019
Initiated
May 20, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Opternative Inc
Quantity
32

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Lack of 510K clearance

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lack of 510K clearance

Code information

ALL

Distribution pattern

Worldwide distribution. US Nationwide distribution in the states of AZ, CA, DE, FL, IL, MO, NV, NY, OH, PA, TX, WA, and UT. Country of Canada.