Recall Z-2163-2025 · LPL Lenses, Soft Contact, Daily Wear
Johnson & Johnson Vision Care, Inc.
ACUVUE OASYS MAX 1-Day MULTIFOCAL
| Date | Jul 23, 2025 (initiated Jun 12, 2025) |
| Status | Open, Classified |
| Reason | Due to defects (bubbles/voids) identified during standard finished goods testing |
| Root cause | Nonconforming Material/Component |
| Action | On 06/12/2025, the firm sent via FedEx an "URGENT: MEDICAL DEVICE RECALL" letter to customers to inform them that the firm identified high density of microbubbles (microscopic voids within the contact lens) observed in specific limited lots during our quality control checks. Customers are instructed to: 1. Review if any of their inventory contains contact lenses impacted lot numbers. 2. STOP using and remove from their inventory all affected product. Note: They can continue to use all other lots not affected by this voluntary recall. 3. Pass this notice on to anyone in their organization who |
| Quantity | 114,165 lenses |
| 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 K |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210930 | ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) Johnson & Johnson Vision Care, Inc., Nov 29, 2021 |