CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report
(Stenfilcon A) Contact Lens recalled by CooperVision
CooperVision is recalling (Stenfilcon A) Contact Lens, distributed nationwide in the US. The recall was initiated on 27 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1455-2025
- FDA event ID
- 96396
- Recalling firm
- CooperVision, West Henrietta, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Feb 2025
- FDA classified
- 25 Mar 2025
- Reported
- 2 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
- Device type
- Contact Lenses & Eye Devices
Timeline
| 27 Feb 2025 | Recall initiated by company | |
| 25 Mar 2025 | Classified by FDA | +26 days |
| 2 Apr 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
a limited number of lots were manufactured with an incorrect cylinder power.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide CaliforniaColoradoFloridaIllinoisKentuckyMichiganNorth CarolinaNebraskaNew JerseyNew YorkOhioOregonUtahVirginiaWashington
Stores named: Costco
Questions about this recall
Is (Stenfilcon A) Contact Lens recalled?
Yes. CooperVision recalled (Stenfilcon A) Contact Lens on 27 Feb 2025. The recall is Class II and its status is Ongoing. Recall number Z-1455-2025.
Why was it recalled?
a limited number of lots were manufactured with an incorrect cylinder power.
Which lots are affected?
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;
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from CooperVision
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision | CooperVision | Mold | Nationwide |
| Device | CLASS II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled | CooperVision | Mold | Nationwide |
| Device | CLASS II | MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision | CooperVision | Mold | Nationwide |
| Device | CLASS II | Biofinity Toric Multifocal Contact Lens recalled by CooperVision | CooperVision | Sterility | Nationwide |
| Device | CLASS II | Biofinity XR Toric Contact Lens recalled by CooperVision | CooperVision | Sterility | Nationwide |
Other Contact Lenses & Eye Devices recalls
All 152| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled | AMO Puerto Rico Manufacturing | Sterility | Nationwide |
| Device | CLASS II | Alcon PRECISION1 One-Day Contact Lenses, -2.25D recalled | Alcon Research | Sterility | 19 states |
| Device | CLASS II | Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision | CooperVision | Mold | Nationwide |
| Device | CLASS II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled | CooperVision | Mold | Nationwide |
| Device | CLASS II | MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision | CooperVision | Mold | Nationwide |