The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1335-2013·Announced 2013-05-22

Johnson & Johnson Recalls 1-DAY ACUVUE MOIST Contact Lenses for Sealing Defects

Johnson & Johnson Vision Care is recalling 1-DAY ACUVUE MOIST contact lenses because some packages may not be completely sealed.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard involves packaging integrity rather than a direct chemical or biological contamination, and no illnesses or injuries are reported in the source text.

Plain-English summary

Johnson & Johnson Vision Care, Inc. is recalling 36,330 units of 1-DAY ACUVUE MOIST Brand Contact Lenses. The recall involves soft disposable contact lenses indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia. The specific issue is that a limited number of individual contact lens packages may not have been completely sealed.

The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries such as Canada, the United Kingdom, and Germany. Specific lot numbers involved in the recall include 2054890422, 2054890521, 2054895620, 1536500620, and 2138800422, covering various diopter strengths.

Consumers who have these specific lot numbers should check their packages to ensure they are completely sealed. If a package is not sealed, consumers should stop using the lenses and contact Johnson & Johnson Vision Care for further instructions.

The recalled product

Product
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…
Manufacturer
Johnson & Johnson Vision Care, Inc.
Category
Medical Device — Contact Lenses
Hazard
Affected units
36,330

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

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

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Johnson & Johnson Vision Care, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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