Recall Z-1282-2023— CooperVision, Inc.

Name: FDA recall Z-1282-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-14

Class II · Ongoing

Class II FDA medical device recall by CooperVision, Inc., initiated 2023-02-14. It names one FDA 510(k) clearance: K181920. Product: Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90. Reason: The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power..

Recalling firm: CooperVision, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-02-14
Firm location: West Henrietta, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K181920 — Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV BlockerCooperVision, Inc.·cleared 2018-12-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90

Reason for recall

The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.

Data sourced from openFDA. This site is unofficial and independent of the FDA.