FDA recall Z-2163-2025

Johnson & Johnson Vision Care, Inc. · Class II · device

Product

ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL

Reason for recall

Due to defects (bubbles/voids) identified during standard finished goods testing

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2025-06-12
Report date
2025-07-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Jacksonville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2163-2025