FDA recall, , Moderate risk
CooperVision Softmed Breathables Advanced Toric Contact Lenses
The contact lens is labeled for extended wear but is intended for daily wear only.
Summary by Recall Canary from the FDA notice
What happened
CooperVision, Inc. is recalling Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens because the carton packaging incorrectly states the product is "Indicated for Extended Wear". The 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.
The recall began on September 22, 2026, and was added to the FDA's Enforcement Report on October 22, 2026. The product is a 55% water content, toric, silicone hydrogel contact lens for daily wear, frequent replacement, blister packaged. Distribution was US Nationwide in the states of FL, KY, MI.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Incomplete list: 40 of 4,101 UDI-DIs shown.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
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.- UDI-DI
- 19486120027517
- 19486120030515
- 19486120035532
- 19486120051506
- 19486170015507
- 19486170016513
- 19486170016521
- 19486170017507
- 19486170017509
- 19486170017512
- 19486170019512
- 19486170019514
- 19486170021021
- 19486170021518
- 19486170022503
- 19486170022504
- 19486170023528
- 19486170025508
- 19486170026021
- 19486170027034
- 19486170027504
- 19486170027524
- 19486170028518
- 19486170030023
- 19486170030034
- 19486170031023
- 19486170031034
- 19486170032030
- 19486170032036
- 19486170032504
- 19486170033501
- 19486170034001
- 19486170034032
- 19486170034038
- 19486170039040
- 19486170040030
- 19486170041032
- 19486170042018
- 19486170042032
- 19486170043003
Recall details
- Company began the recall
- Company
- CooperVision, Inc.
- Hazard
- Unapproved product
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99936
- Recall number
- Z-0204-2027
All recalls from CooperVision, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
