CLASS II Device recall · Reported 23 Jun 2021 · FDA Enforcement Report

Acuvue Vita soft (hydrophilic) contact lens (spherical) recalled

Johnson & Johnson Vision Care is recalling Acuvue Vita soft (hydrophilic) contact lens (spherical) for daily wear, distributed nationwide in the US. The recall was initiated on 6 May 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUPC 733905989612 LOT # BOOWWWL

Quantity recalled6,780 lenses

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1865-2021
FDA event ID: 87947
Recalling firm: Johnson & Johnson Vision Care, Jacksonville, FL
Classification: Class II
Status: Terminated
Recall initiated: 6 May 2021
FDA classified: 16 Jun 2021
Reported: 23 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Contact Lenses & Eye Devices

Timeline

6 May 2021	Recall initiated by company
16 Jun 2021	Classified by FDA	+41 days
23 Jun 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential that a limited number of individual contact lens packages have an incomplete packaging seal.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50

Where it was distributed

Worldwide Distribution. US nationwide, Canada, Germany, Austria, Belgium, France, Luxemburg, Netherland, Portugal, Spain, Sweden, Switzerland, and Trinidad and Tobago.

Nationwide

Questions about this recall

Why was it recalled?

Potential that a limited number of individual contact lens packages have an incomplete packaging seal.

Which lots are affected?

UPC 733905989612 LOT # BOOWWWL

Where was it sold?

Worldwide Distribution. US nationwide, Canada, Germany, Austria, Belgium, France, Luxemburg, Netherland, Portugal, Spain, Sweden, Switzerland, and Trinidad and Tobago.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Johnson & Johnson Vision Care

All 10

Reported	Class	Recall	Company	Reason	Where
30 Jul 2025Device	CLASS II	Acuvue¿ Oasys Max 1-Day Multifocal recalled	Johnson & Johnson Vision Care	Device Malfunction	Nationwide
29 Apr 2020Device	CLASS II	Acuvue Oasys for Astigmatism Contact Lenses recalled	Johnson & Johnson Vision Care	Packaging Defects	Nationwide
17 Apr 2019Device	CLASS II	Acuvue Oasys for Astigmatism contact lenses recalled	Johnson & Johnson Vision Care	Packaging Defects	CA
29 Aug 2018Device	CLASS II	1-Day Acuvue Moist Daily Wear, 8.5 Base Curve, -3.25 Power recalled	Johnson & Johnson Vision Care	Packaging Defects	Nationwide
4 Apr 2018Device	CLASS II	1-Day Acuvue Moist for Astigmatism Contact Lenses recalled	Johnson & Johnson Vision Care	Foreign Material	Nationwide

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