ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR
FDA Device Recall #Z-1210-2018 — Class II — October 19, 2017
Recall Summary
| Recall Number | Z-1210-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 19, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Johnson & Johnson Vision Care, Inc. |
| Location | Jacksonville, FL |
| Product Type | Devices |
| Quantity | 165,750 |
Product Description
ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR
Reason for Recall
Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.
Distribution Pattern
Worldwide distribution. US nationwide including Puerto Rico, Korea, Czech Republic, China, Japan, Great Britain, Austria, Malaysia, Hong Kong, Russia, Taiwan, Singapore, India, and Brazil
Lot / Code Information
Lot B00DHLP Exp. 08/2018 Base Curve 8.7, Refractive Power -10.00D - Manufactured in J&J Vision Care Inc. Jacksonville, FL Lot L002FNL Exp. 07/2020 Base Curve 8.7 Refractive Power -4.75D Manufactured in J&J Vision Care Ireland Lot L002V94 Exp. 01/2022 Base Curve 8.7 Refractive Power -5.00D
Other Recalls from Johnson & Johnson Vision Care, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2163-2025 | Class II | ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL | Jun 12, 2025 |
| 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 |
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.