Johnson & Johnson Vision Care, Inc.: Device Recall
Recall #Z-2163-2025 · 06/12/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2163-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Johnson & Johnson Vision Care, Inc.
- Status
- Ongoing
- Date Initiated
- 06/12/2025
- Location
- Jacksonville, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 114,165 lenses
Reason for Recall
Due to defects (bubbles/voids) identified during standard finished goods testing
Product Description
ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
Distribution Pattern
Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, PA, SC TN, TX, UT, VA, WA, WI, and WY. The countries of Belgium, Bermuda, Canada, Switzerland, Denmark, Germany, Spain, France, United Kingdom, Italy, Netherlands, Poland, Sweden, Singapore, and South Korea.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.