AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker

FDA Device Recall #Z-2144-2021 — Class II — May 19, 2021

Recall Summary

Recall Number Z-2144-2021
Classification Class II — Moderate risk
Date Initiated May 19, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm CooperVision Inc.
Location West Henrietta, NY
Product Type Devices
Quantity 720 lenses

Product Description

AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker

Reason for Recall

Misaligned placement of an axis mark can cause the patient to experience blurred vision

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of FL, NY, TN, OH, NC, WI and the countries of France, United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, Canada.

Lot / Code Information

Lot Number: R0121629

Other Recalls from CooperVision Inc.

Recall # Classification Product Date
Z-2147-2021 Class II CLARITI 1 DAY TORIC Power -07.00 -1.25/180 ... May 19, 2021
Z-2146-2021 Class II CLARITI 1 DAY TORIC Power -07.00 -1.75/170 ... May 19, 2021
Z-2148-2021 Class II SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 ... May 19, 2021
Z-2150-2021 Class II CLARITI 1 DAY TORIC Power -07.00 -1.75/170 ... May 19, 2021
Z-2153-2021 Class II FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 ... May 19, 2021

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.