Recall Z-0204-2027 ยท LPL Lenses, Soft Contact, Daily Wear
CooperVision, Inc.
Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: Softmed Breathables Advanced Toric Product Description: 55% water content, toric, silicone hydrogel contact lens for daily wear, frequent replacement. Blister packaged.
| Date | Oct 22, 2026 (initiated Sep 22, 2026) |
| Status | Open, Classified |
| Reason | The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended for daily wear, and the extended-wear statement should not have appeared on the affected carton labeling. This product is not approved by the U.S. Food and Drug Administration (FDA) for extended wear use. |
| Root cause | Labeling design |
| Action | On September 22, 2026, URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Examine product in your possession for any affected product. 2. If the product packaging bears the Indicated for Extended Wear statement or the lot number on the carton appears in the list of affected lot numbers, please stop any further use or distribution of products from the designated lot number(s). 3. Please return the product to your authorized distributor or your Eye Care Practitioner. 4. We recommend Eye Care Practitioners contact your patients who have received the affected p |
| Quantity | 230856 |
| Distribution | US Nationwide distribution in the states of FL, KY, MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens CooperVision, Inc., Jul 13, 2016 |
| K213164 | Avaira Vitality CooperVision, Inc., Oct 26, 2021 |
| K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) CooperVision, Inc., Feb 4, 2022 |