Recall Z-1282-2023 ยท LPL Lenses, Soft Contact, Daily Wear
CooperVision, Inc.
Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
| Date | Mar 23, 2023 (initiated Feb 14, 2023) |
| Status | Open, Classified |
| 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 Practiti |
| Quantity | 3150 |
| Distribution | Worldwide - US Nationwide distribution in the states of FL, IL, NY, UT, and WI. The country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker CooperVision, Inc., Dec 11, 2018 |