The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1210-2018·Announced 2018-04-04

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

Johnson & Johnson Vision Care is recalling specific lots of ACUVUE ADVANCE 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 describes a packaging defect (foreign matter between blister and foil) without reporting any injuries, illnesses, or hospitalizations. This aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls where harm has not been reported.

Plain-English summary

Johnson & Johnson Vision Care, Inc. is recalling specific lots of ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR. The recall involves 165,750 units distributed worldwide, including the United States (including Puerto Rico), Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil.

The recall was initiated because some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil. The affected lots include Lot B00DHLP (Exp. 08/2018, Base Curve 8.7, Refractive Power -10.00D), Lot L002FNL (Exp. 07/2020, Base Curve 8.7, Refractive Power -4.75D), and Lot L002V94 (Exp. 01/2022, Base Curve 8.7, Refractive Power -5.00D).

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

The recalled product

Product
ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR
Manufacturer
Johnson & Johnson Vision Care, Inc.
Category
Medical Device — Contact Lenses
Hazard
Affected units
165,750

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 (2)

  • Lot B00DHLP Exp. 08/2018 Base Curve 8.7
  • Refractive Power -10.00D - Manufactured in J&J Vision Care Inc. Jacksonville

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 →

Related recalls

Same manufacturer · Johnson & Johnson Vision Care, Inc.

See all →

Same hazard · foreign matter

See all →

Similar recalls