ACUVUE OASYS MAX multifocal daily lenses have bubbles and voids
ACUVUE OASYS MAX 1-Day MULTIFOCAL contact lenses are being recalled because of defects, specifically bubbles and voids, identified during standard finished goods testing. 114,165 lenses affected.
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: FDA Class II recall for a manufacturing defect found in routine testing, with no clinical consequence or sterility failure stated in the source.
Plain-English summary
ACUVUE OASYS MAX 1-Day MULTIFOCAL contact lenses are being recalled across the lot numbers, product descriptions and UPC numbers listed in the recall notice. The action covers 114,165 lenses.
The stated reason is defects, specifically bubbles and voids, identified during standard finished goods testing. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Distribution was worldwide, including nationwide in the United States across Alabama, Arizona and California among other states.
Wearers and eye care practitioners should identify affected stock using the lot numbers in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- Product
- ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
- Manufacturer
- Johnson & Johnson Vision Care, Inc.
- Category
- Medical Device — Contact lens
- Affected units
- 114,165
Distribution
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