Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigm...
FDA Device Recall #Z-1455-2025 - Class II, February 27, 2025
Recall Summary
| Recall Number | Z-1455-2025 |
| Classification | Class II - Moderate risk |
| Date Initiated | February 27, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | CooperVision, Inc. |
| Location | West Henrietta, NY |
| Product Type | Devices |
| Quantity | 33990 lenses (17010 US, 16980 OUS) |
Product Description
Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, REVEAL 1-DAY TORIC, Vision Source Reveal Toric, Voyant 1-Day Premium Toric. Brand Names (OUS only): CADENCE DELUXE 1-DAY TORIC, DUBLAN PREMIUM OXYGEN 1 DAY TORIC, EV LINARIAL TORIC (30), EYEXPERT PURE ASTIGMATISM (30), LENTI!!AS A ASTIGMATISMO 30PK, LENTSOFT DIARIA CONFORT+ SILICONA ASTIGMATISMO, MULTILENS CONTACT ELITE SILICONE 1 DAY TORICS, OPTIONS SUPREME 1 DAY TRC (30), PRIMA + 1 DAY ASTGM (30), PROTECT PLATINUM FOR ASTG (30), SOL- LENS 1 DAY SILICONE PREMIUM TORIC, UGO LENS DAY ADVANCED TORICA, WHITE BOX STENFILCON A TORIC 07536, MEDIFLEX SUP 1D TORIC, Kirkland Signature Toric Premium Daily Disposable, Specsavers easyvision Linarial Toric. Product Name: (Stenfilcon A) Contact Lens Model/Catalog Number: MyDay Toric Product Description: 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged. Component: No
Reason for Recall
a limited number of lots were manufactured with an incorrect cylinder power.
Distribution Pattern
Domestic: CA, CO, FL, IL, KY, MI, NC, NE, NJ, NY, OH, OR, UT, VA, WA. International: Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Italy, Luxembourg, Netherlands, New Zealand, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and United Kingdom.
Lot / Code Information
Blister Lot Numbers: (1) 6461501582, (2) 6461501590, (3) 6448502235, (4) 6472500679. Carton Lot numbers: (1) 19346502595028, (2a) 344446500117, (2b) 19346502613, (2c) 21455502575, (3a) 21476504025, (3b) 21545502813, (3c) 24127502235, (3d) 40702500019, (4a) 21512501331, (4b) 21492501653, (4c) 21492501685;
Other Recalls from CooperVision, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2606-2025 | Class II | MyDay Toric, stenfilcon A) Contact Lens. Model/... | Aug 22, 2025 |
| Z-2608-2025 | Class II | Voyant 1-Day Premium Toric, (stenfilcon A) cont... | Aug 22, 2025 |
| Z-2607-2025 | Class II | Sofmed Breathables, (stenfilcon A) contact lens... | Aug 22, 2025 |
| Z-2165-2025 | Class II | Biofinity XR Toric Contact Lens | Jun 16, 2025 |
| Z-2166-2025 | Class II | Biofinity Toric Multifocal Contact Lens | Jun 16, 2025 |
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.