FDA Medical Device Recalls (openFDA)
CooperVision, Inc.: Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
- Recall number
- Z-1282-2023
- Recalling firm
- CooperVision, Inc.
- Product
- Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
- Status
- Open, Classified
- Initiated
- 2023-02-14
- Posted
- 2023-03-23
- Terminated
- not on file
- Reason
- The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.
- Root cause
- Process control
- Action
- An URGENT MEDICAL DEVICE CORRECTION letter dated 2/14/23 was sent to customers. Eye Care Practitioner/Distributor Instructions: Our records indicate you have received product from the affected lot. We request you take the following actions: " Please examine your inventory/product shelf for any of the provided affected lot number. 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 number; " We recommend you contact your Eye Care Practitioners or patients who have received the affected product. Any affected product should be returned to you or CooperVision for replacement or credit. " Enclosed you will find a template letter that can be customized by an Eye Care Practitioner for distribution to their patients. " Within the next five (5) business days, complete the attached Correction Response Form and fax it to 1-888-385-3217 or scan and email to: info@coopervision.com. If you have no lenses from these specified lots, please put 0 in Quantity ; " Your account will be credited once the form is received. " If your patients have questions or complaints, please have them contact our customer services team at 1-800-341-2020, 9:00 AM 7:00 PM ET, Monday Friday, or they can visit CooperVision s website at coopervision.com/our-company/contact-us/complaint. 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. We appreciate your assistance and apologize for any inconvenience to you or your customers. Should you wish to discuss this action, please contact your business development manager or our CooperVision Customer Service at: 1-800-341-2020, 9:00 AM 7:00 PM ET,
- Quantity
- 3150
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, IL, NY, UT, and WI. The country of Canada.
- Lot, serial or model codes
- Lot Number W0124677
- 510(k) numbers
- ["K181920"]
- PMA numbers
- not on file
- Product code
- LPL
- 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