Z-1197-2023Class II

Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)

Name: Z-1197-2023 Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Creator: CooperVision, Inc.
Published: 2023-01-26
License: https://open.fda.gov/license/

CooperVision, Inc. / initiated 2023-01-26 / Open, Classified / root cause: manufacturing process

FDA source

CooperVision, Inc. began a recall of Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear) on 2023-01-26. FDA classified it as Class II and gives the reason as "Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1197-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-01-26
Posted: 2023-03-01
Recalling firm: CooperVision, Inc.
Product: Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Product code: LPM Lenses, Soft Contact, Extended Wear
Reason for recall: Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Coopervision issued Urgent Medical Device Correction letter on 1/26/23 to direct consignees requesting end users be notified. Letter states reason for recall, health risk and action to take: Please examine your inventory/product shelf for any of the provided affected lot numbers. The lot number can be found on the back panel of the carton below the expiration date. Below is an example and where to locate the lot number. " Stop any further distribution of product from the designated lot numbers; " We recommend you contact your Eye Care Practitioners or patients who have received the affected product. Please instruct Eye Care Practitioners or patients to return any affected product to you for replacement or credit. " Enclosed you will find a template that can be customized by the ECP for distribution to their patients. Please note that if a credit is due to you, this will automatically be applied to your account once we have received and validated your Correction Response Form . This action is being reported to applicable health authorities and CooperVision may be required to identify any consignees that do not respond. Should you wish to discuss this action, please contact your business development manager or our customer services team at: 800-341-2020, 9:00 AM 7:00 PM ET, Monday Friday.
Quantity in commerce: 24 units
Distribution: US Nationwide distribution in the states of CA, OH, NC, PA.
Product codes and lots: UDI: N/A Lot Numbers: R24377024, R24377026, R24381716, R24416900

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1197-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1197-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-03-01
Z-1198-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-08	2023-03-01

Product code LPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)