Johnson & Johnson recalls Acuvue Oasys Max contact lenses for manufacturing defects
Johnson & Johnson Vision Care is recalling 114,165 Acuvue Oasys Max 1-Day Multifocal contact lenses due to bubbles and voids found during quality testing. The defects were identified during standard finished goods inspection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving defects in contact lenses that directly contact the eye. While no illnesses or injuries have been reported and the defect was identified during quality control testing, bubbles and voids represent a risk of potential harm to users. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Johnson & Johnson Vision Care, Inc. is recalling 114,165 units of Acuvue Oasys Max 1-Day Multifocal contact lenses due to manufacturing defects consisting of bubbles and voids. These defects were identified during the company's standard finished goods testing process.
The affected lenses are distributed worldwide, including throughout the United States in all 50 states, as well as in Belgium, Bermuda, Canada, Switzerland, Denmark, Germany, Spain, France, United Kingdom, Italy, Netherlands, Poland, Sweden, Singapore, and South Korea. Multiple lens prescriptions and configurations are included in this recall.
Consumers who have purchased affected lenses should stop use and contact their eye care professional or the manufacturer for guidance. Individuals may return the lenses to the retailer where they were purchased or contact Johnson & Johnson Vision Care for return instructions.
The recalled product
- Product
- ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
- Manufacturer
- Johnson & Johnson Vision Care, Inc.
- Category
- Medical Device — Contact Lenses
- Hazard
- bubbles-voids
- manufacturing-defect
Distribution
Distributed nationwide across the United States.
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