Class II U.S. Food and Drug Administration

CooperVision, Inc recall: The affected products bear an incorrect statement on the carton packaging

Recall published 5 days ago

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.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0204-2027
Published
October 28, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
CooperVision, Inc.
Product type
Medical devices
Units affected
230856
Distribution
Nationwide
Made in
United States
Lot / code info
Model/Catalog Number: Softmed Breathables Advanced Toric; UDI-DI: N/A Lot numbers: 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, 19486170043028, 19486170043030, 19486170043032, 19486170043502, 19486170044017, 19486170045011, 19486170047002, 19486170047007, 19486170047011, 19486170048011, 19486170049004, 19486170049006, 19486170049009, 19486170049011, 19486170050003, 19486170050004, 19486170050007, 19486170050019, 19486170051002, 19486170051006, 19486170051024, 19486170052002, 19486170052005, 19486170052009, 19486170052015, 19486170053015, 19486170053024, 19486170054015, 19486170054016, 19486170055000, 19486170055018, 19486170055026, 19486170056000, 19486170056014, 19486170057005, 19486170059018, 19486170060008, 19486170060012, 19486170060014, 19486170061008, 19486170061014, 19486170061018, 19486170064014, 19486170065008, 19486170068010, 19486170069010, 19487120020526, 19487120026512, 19487120027506, 19487120043038, 19487120046502, 19487120048036, 19487120051003, 19487120061007, 19487120067007, 19487120071014, 19487120075016, 19487120077016, 19487120079014, 19487120080014, 19487170006516, 19487170012505, 19487170015501, 19487170016524, 19487170017030, 19487170019503, 19487170022001, 19487170022021, 19487170023021, 19487170025011, 19487170026019, 19487170028011, 19487170028013, 19487170029019, 19487170030017, 19487170030019, 19487170031026, 19487170031028, 19487170031032, 19487170032011, 19487170032017, 19487170032024, 19487170033005, 19487170033009, 19487170034002, 19487170034015, 19487170035002, 19487170035022, 19487170036020, 19487170037000, 19487170037011, 19487170038005, 19487170038018, 19487170039018, 19487170040000, 19487170042000, 19487170044000, 19487170047006, 19487170048012, 19487170053008, 19488120012522, 19488120015512, 19488120017519, 19488120023021, 19488120030013, 19488120032017, 19488120033028, 19488120034005, 19488120035018, 19488120037018, 19488120042020, 19488120044000, 19488170005507, 19488170006504, 19488170007501, 19488170007507, 19488170010508, 19488170015015, 19488170016032, 19488170019026, 19488170020009, 19488170021004, 19488170022004, 19488170022006, 19488170022014, 19488170024012, 19488170028016, 19488170028026, 19489120015504, 19489120015512, 19489120019009, 19489120019021, 19489120019036, 19489120024040, 19489120027007, 19489120027018, 19489120027024, 19489120029020, 19489120030000, 19489120031016, 19489120036006, 19489170005508, 19489170009030, 19489170010002, 19489170010010, 19489170012003, 19489170014028, 19490120013023, 19490120024002, 19490120024005, 19490120025007, 19490120026013, 19490170003508, 19490170007524, 19490170008501, 19490170012004, 19490170015006, 19490170015010, 19491120017021, 19491120017511, 19491120026014, 19491120034012, 19491120037008, 19491170004508, 19491170006503, 19491170007503, 19491170008504, 19491170016024, 19491170017002, 19491170021000, 19492120009511, 19492120010034, 19492120026024, 19492120027018, 19492120034011, 19492120048000, 19492120052000, 19492170004518, 19492170005520, 19492170018010, 19492170022002, 19492170022005, 19492170024008, 19492170025001, 19492170027003, 19492170027004, 19492170028002, 19492170028004, 19493120013513, 19493120015512, 19493120017518, 19493120021020, 19493120022028, 19493120022030, 19493120026018, 19493120026506, 19493120037013, 19493120042501, 19493120045009, 19493170006017, 19493170010015, 19493170010016, 19493170010017, 19493170010507, 194931700130…
UPC codes
19486120027517, 19486120030515, 19486120035532, 19486120051506, 19486170015507, 19486170016513, 19486170016521, 19486170017507, 19486170017509, 19486170017512, 19486170019512, 19486170019514, 19486170021021, 19486170021518, 19486170022503, 19486170022504, 19486170023528, 19486170025508, 19486170026021, 19486170027034

Products covered by this recall

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.

Check your product

The notice names 25 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 19486120027517
  • 19486120030515
  • 19486120035532
  • 19486120051506
  • 19486170015507
  • 19486170016513
  • 19486170016521
  • 19486170017507
  • 19486170017509
  • 19486170017512
  • 19486170019512
  • 19486170019514
  • 19486170021021
  • 19486170021518
  • 19486170022503
  • 19486170022504
  • 19486170023528
  • 19486170025508
  • 19486170026021
  • 19486170027034

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 19486120027517
  • 19486120030515
  • 19486120035532
  • 19486120051506
  • 1948617

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

CooperVision, Inc. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: CooperVision, Inc. — 180 Thruway Park Dr, West Henrietta, NY, 14586-9798

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was CooperVision, Inc. medical devices recalled?

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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 19486120027517, 19486120030515, 19486120035532; lot code 19486120027517, 19486120030515, 19486120035532. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls