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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64468

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

Open FDA event record

Event summary

Timeline bucket
December 21, 2012
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

2 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 2

1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. The Vistakon (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically), with UV Blocker for Daily Disposable Wear (spherical) is indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism.

Z-1335-2013
Recall number
Z-1335-2013
Initiated
December 21, 2012
Classification
Class II
Status
Terminated
Quantity
36,330 lenses

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Limited number of individual contact lens packages may not have been completely sealed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Limited number of individual contact lens packages may not have been completely sealed.

Code information

Lot Numbers: 2054890422, +2.25D 2054890521, + 2.25D 2054895620, + 2.25D 1536500620, -3.75D 2138800422, -4.75D

Distribution pattern

Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and Puerto Rico; and countries of: Austria, Belgium, Canada, Costa Rica, Denmark, France, Germany, Hungary, India, Ireland, Israel, Italy, Korea, Japan, Luxembourg, Netherlands, Portugal, Norway, South Africa, Slovenia, Spain, Sweden, and United Kingdom.

device · product 2 of 2

ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses. The Vistakon (galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less.

Z-1336-2013
Recall number
Z-1336-2013
Initiated
December 21, 2012
Classification
Class II
Status
Terminated
Quantity
3546 lenses

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Limited number of individual contact lens packages may not have been completely sealed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Limited number of individual contact lens packages may not have been completely sealed.

Code information

Lot Codes: B00DJPQ, -7.00D B00DMHZ, -6.00D B00DMJP, +4.00D

Distribution pattern

Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI and Puerto Rico; and countries of: Austria, Belgium, Canada, Costa Rica, Denmark, France, Germany, Hungary, India, Ireland, Israel, Italy, Korea, Japan, Luxembourg, Netherlands, Portugal, Norway, South Africa, Slovenia, Spain, Sweden, and United Kingdom.