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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71014

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

Open FDA event record

Event summary

Timeline bucket
February 27, 2015
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Volk Optical 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

Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.

Z-1685-2015
Recall number
Z-1685-2015
Initiated
February 27, 2015
Classification
Class III
Status
Terminated
Recalling firm
Volk Optical Inc
Quantity
6 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Mislabeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring.

Code information

Model #V25LC, Lot: BE09243

Distribution pattern

Worldwide Distribution - US Distribution to the states of : MA and VA., and to the countries of Mexico and Sweden.