Z-1282-2023 Class II Ongoing

Recalled by CooperVision, Inc. — West Henrietta, NY

FDA device recall Z-1282-2023 was initiated by CooperVision, Inc. on February 14, 2023 and is designated Class II. Reason for recall: The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power. The recall status is ongoing. Affected quantity: 3150.

Recall Details

Product Type
Devices
Report Date
March 29, 2023
Initiation Date
February 14, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3150

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.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of FL, IL, NY, UT, and WI. The country of Canada.

Code Information

Lot Number W0124677