510(k) K131378 ยท LPL Lenses, Soft Contact, Daily Wear
SUS (STENFILCON A) CONTACT LENS
| Applicant | CooperVision, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Aug 30, 2013 |
| Received | May 14, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131378
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2025 | CooperVision, Inc. MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric.
54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blist Open, Classified |
MVN | None listed |
| Sep 19, 2025 | CooperVision, Inc. Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables.
54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wea Open, Classified |
MVN | None listed |
| Sep 19, 2025 | CooperVision, Inc. Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric.
54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Open, Classified |
MVN | None listed |
| Mar 26, 2025 | CooperVision, Inc. 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, Voy Open, Classified |
MVN | None listed |
| Jan 24, 2023 | CooperVision, Inc. MyDay Toric (90-pack)
Reveal 1 Day Toric (90-pack)
Soft (hydrophilic) Contact Lens (daily wear). Single Use. Open, Classified |
LPL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.