Recall Z-2149-2021 ยท LPL Lenses, Soft Contact, Daily Wear
CooperVision Inc.
CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
| Date | May 19, 2021 |
| Status | Terminated |
| 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 Corre |
| Quantity | 10 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130331 | SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER Sauflon Pharmaceuticals, Ltd., Jul 26, 2013 |