ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
FDA Device Recall #Z-2163-2025 - Class II, June 12, 2025
Recall Summary
| Recall Number | Z-2163-2025 |
| Classification | Class II - Moderate risk |
| Date Initiated | June 12, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Johnson & Johnson Vision Care, Inc. |
| Location | Jacksonville, FL |
| Product Type | Devices |
| Quantity | 114,165 lenses |
Product Description
ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
Reason for Recall
Due to defects (bubbles/voids) identified during standard finished goods testing
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.
Lot / Code Information
LOT_NUMBER / PRODUCT_DESCRIPTION / UPC Number J003QC7 1D MAX MULTIFOCAL 8.4 +0.00 LOW 90P RX 888290921027 J003QC8 1D MAX MULTIFOCAL 8.4 +0.50 LOW 90P RX 888290921041 003QC9 1D MAX MULTIFOCAL 8.4 +1.25 HGH 90P RX 888290920464 J003QCB 1D MAX MULTIFOCAL 8.4 +1.25 LOW 90P RX 888290921072 J003QCC 1D MAX MULTIFOCAL 8.4 +1.75 LOW 90P RX 888290921096 J003QCD 1D MAX MULTIFOCAL 8.4 +2.00 MID 90P RX 888290921713 J003QCG 1D MAX MULTIFOCAL 8.4 +2.75 MID 90P RX 888290921744 J003QCH 1D MAX MULTIFOCAL 8.4 -0.50 MID 90P RX 888290921614 J003QCJ 1D MAX MULTIFOCAL 8.4 -0.75 HGH 90P RX 888290920389 J003QHP 1D MAX MULTIFOCAL 8.4 -1.00 LOW 90P RX 888290920983 J003QCK 1D MAX MULTIFOCAL 8.4 -1.25 MID 90P RX 888290921584 J003Q71 1D MAX MULTIFOCAL 8.4 -1.75 MID 30P RX 888290919734 J003Q72 1D MAX MULTIFOCAL 8.4 -2.00 LOW 30P RX 888290919116 J003Q73 1D MAX MULTIFOCAL 8.4 -2.00 MID 30P RX 888290919727 J003Q74 1D MAX MULTIFOCAL 8.4 -2.25 LOW 30P RX 888290919109 J003QHT 1D MAX MULTIFOCAL 8.4 -2.25 LOW 90P RX 888290920938 J003Q75 1D MAX MULTIFOCAL 8.4 -2.25 MID 30P RX 888290919710 J003QCL 1D MAX MULTIFOCAL 8.4 -2.50 HGH 90P RX 888290920389 J003QCM 1D MAX MULTIFOCAL 8.4 -2.50 LOW 90P RX 888290920921 J003Q76 1D MAX MULTIFOCAL 8.4 -2.50 MID 30P RX 888290919703 J003QCQ 1D MAX MULTIFOCAL 8.4 -3.00 MID 90P RX 888290921515 J003QD0 1D MAX MULTIFOCAL 8.4 -3.50 MID 30P RX 888290919666 J003QM9 1D MAX MULTIFOCAL 8.4 -3.50 MID 90P RX 888290921492 J003QD3 1D MAX MULTIFOCAL 8.4 -4.00 LOW 30P RX 888290919031 J003QD4 1D MAX MULTIFOCAL 8.4 -4.00 MID 30P RX 888290919642 J003QD5 1D MAX MULTIFOCAL 8.4 -4.25 HGH 30P RX 888290918416 J003QD9 1D MAX MULTIFOCAL 8.4 -4.75 LOW 30P RX 888290919000 J003QDG 1D MAX MULTIFOCAL 8.4 -5.25 MID 30P RX 888290919598 J003QDH 1D MAX MULTIFOCAL 8.4 -5.50 LOW 30P RX 888290918973 J003QDK 1D MAX MULTIFOCAL 8.4 -5.75 HGH 30P RX 888290918355 J003QHW 1D MAX MULTIFOCAL 8.4 -6.50 MID 90P RX 888290921379 J003QBT 1D MAX MULTIFOCAL 8.4 -6.75 LOW 90P RX 888290920754 J003QCV 1D MAX MULTIFOCAL 8.4 -7.25 LOW 90P RX 888290920730 J003QQH 1D MAX MULTIFOCAL 8.4 -7.50 HGH 90P RX 888290920112 J003QBX 1D MAX MULTIFOCAL 8.4 -7.50 MID 90P RX 888290921331 V00D228 (J003QHT) 1D MAX MULTIFOCAL 8.4 -2.25 LOW 5P DX 888290922772
Other Recalls from Johnson & Johnson Vision Care, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1865-2021 | Class II | ACUVUE VITA soft (hydrophilic) contact lens (sp... | May 6, 2021 |
| Z-1131-2019 | Class II | ACUVUE OASYS for ASTIGMATISM brand contact lens... | Mar 11, 2019 |
| Z-2916-2018 | Class II | Johnson and Johnson Vision Care 1-Day ACUVUE MO... | Jul 23, 2018 |
| Z-1744-2020 | Class II | ACUVUE OASYS for ASTIGMATISM Brand Contact Lens... | Dec 18, 2017 |
| Z-1210-2018 | Class II | ACUVUE ADVANCE Brand Contact Lenses with HYDRAC... | Oct 19, 2017 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.