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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82402

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

Open FDA event record

Event summary

Timeline bucket
March 11, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Johnson & Johnson Vision Care, 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

ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack.

Z-1131-2019
Recall number
Z-1131-2019
Initiated
March 11, 2019
Classification
Class II
Status
Terminated
Quantity
300 lenses

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete packaging

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

One lot of ACUVUE OASYS¿ for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete packaging seal.

Code information

Lot Number on box and individual contact lens package: B00RWF0. UPC: 733905669460

Distribution pattern

Distributed to California.