FDA Medical Device Recalls (openFDA)
CooperVision, Inc.: Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
- Recall number
- Z-1197-2023
- Recalling firm
- CooperVision, Inc.
- Product
- Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
- Status
- Open, Classified
- Initiated
- 2023-01-26
- Posted
- 2023-03-01
- Terminated
- not on file
- Reason
- Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
- 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
- 24 units
- Distribution
- US Nationwide distribution in the states of CA, OH, NC, PA.
- Lot, serial or model codes
- UDI: N/A Lot Numbers: R24377024, R24377026, R24381716, R24416900
- 510(k) numbers
- not on file
- PMA numbers
- ["P080011"]
- Product code
- LPM
- Firm FEI
- 3005724763
- Firm city
- West Henrietta
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28