1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses

FDA Device Recall #Z-1211-2018 — Class II — October 19, 2017

Recall Summary

Recall Number Z-1211-2018
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 56,070

Product Description

1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses

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 B00LF41 Exp. 04/2021 Base Curve 8.5 Refractive Power -7.50D -1.25/180 Manufactured at J&J Vision Care Inc. Jacksonville, FL

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.