The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1209-2018·Announced 2018-04-04

Johnson & Johnson Recalls ACUVUE OASYS Contact Lenses Due to Foreign Matter

Johnson & Johnson Vision Care is recalling specific lots of ACUVUE OASYS contact lenses because foreign matter was found between the blister package and foil.

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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a packaging defect (foreign matter) rather than a high-risk pathogen or structural failure, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Johnson & Johnson Vision Care, Inc. is recalling 125,763 units of ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS. The recall involves 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), both manufactured at J&J Vision Care Ireland.

The recall was initiated because some contact lenses were associated with complaints of foreign matter caught between the blister package and foil. The affected products were distributed worldwide, including in the United States (including Puerto Rico), Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil.

Consumers who have these specific lots of contact lenses should stop using them and contact Johnson & Johnson Vision Care for further instructions.

The recalled product

Product
ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS
Manufacturer
Johnson & Johnson Vision Care, Inc.
Category
Medical Device — Contact Lenses
Hazard
Affected units
125,763

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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