FDA Medical devices recall ·
Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable… recall
- Recall number
- Z-1455-2025
- Date
- (initiated February 27, 2025)
- Company / brand
- CooperVision, Inc.
180 Thruway Park Dr, West Henrietta, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 33990 lenses (17010 US, 16980 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
a limited number of lots were manufactured with an incorrect cylinder power.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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;
Distribution
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.
States: California Colorado Florida Illinois Kentucky Michigan North Carolina Nebraska New Jersey New York Ohio Oregon Utah Virginia Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1455-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.