FDA Medical Device Recalls (openFDA)
CooperVision Inc.: CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
- Recall number
- Z-2147-2021
- Recalling firm
- CooperVision Inc.
- Product
- CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
- Status
- Terminated
- Initiated
- 2021-05-19
- Posted
- not on file
- Terminated
- 2023-03-13
- Reason
- Misaligned placement of an axis mark can cause the patient to experience blurred vision
- Root cause
- Equipment maintenance
- Action
- Coopervision issued Urgent Medical Device Correction letter on 5/19/21 to wholesale/distributor and Eye Care Practitioner level. The independent accounts via overnight FedEx (receipt tracking). Distributors and corporate accounts via email, with a read receipt. Letter states reason for recall, health risk and action to take: Examine your inventory for the affected lot numbers on the enclosed Ship Report. " Stop any further distribution of the specified lots of clariti 1 day toric lenses. " Dispose of the product and, within the next five (5) business days, please complete the attached Correction Response Form and fax it to 866-484-1048 or scan and email to: info@coopervision.com. Your account will be credited once the form is received. If you have any further questions, please feel free to contact CooperVision Customer Service at 800-341-2020, 9:00 AM 7:00 PM ET, Monday Friday.
- Quantity
- 1260 lenses
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, NY, TN, OH, NC, WI and the countries of France, United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, Canada.
- Lot, serial or model codes
- Lot Number: U0108940
- 510(k) numbers
- ["K130331"]
- 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