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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79152

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 19, 2017
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

3 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 3

ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS

Z-1209-2018
Recall number
Z-1209-2018
Initiated
October 19, 2017
Classification
Class II
Status
Terminated
Quantity
125,763

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign matter

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.

Code information

Lot L002NCS exp. 05/2020 base Curve 8.8 Refractive Power -4.00D and Lot L002QH9 exp. 08/2020 Base Curve 8.8 Refractive Power -4.50D Manufactured at J&J Vision Care Ireland

Distribution pattern

Worldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil

device · product 2 of 3

ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR

Z-1210-2018
Recall number
Z-1210-2018
Initiated
October 19, 2017
Classification
Class II
Status
Terminated
Quantity
165,750

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign matter

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.

Code information

Lot B00DHLP Exp. 08/2018 Base Curve 8.7, Refractive Power -10.00D - Manufactured in J&J Vision Care Inc. Jacksonville, FL Lot L002FNL Exp. 07/2020 Base Curve 8.7 Refractive Power -4.75D Manufactured in J&J Vision Care Ireland Lot L002V94 Exp. 01/2022 Base Curve 8.7 Refractive Power -5.00D

Distribution pattern

Worldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil

device · product 3 of 3

1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses

Z-1211-2018
Recall number
Z-1211-2018
Initiated
October 19, 2017
Classification
Class II
Status
Terminated
Quantity
56,070

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign matter

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.

Code information

Lot B00LF41 Exp. 04/2021 Base Curve 8.5 Refractive Power -7.50D -1.25/180 Manufactured at J&J Vision Care Inc. Jacksonville, FL

Distribution pattern

Worldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil

Field note

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