FDA recall Z-1282-2023

CooperVision, Inc. · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2023-02-14
Report date
2023-03-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
West Henrietta, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1282-2023