FDA recall Z-2149-2021

CooperVision Inc. · Class II · device

Product

CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker

Reason for recall

Misaligned placement of an axis mark can cause the patient to experience blurred vision

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.

Key facts

Status
Terminated
Initiation date
2021-05-19
Report date
2021-08-04
Termination date
2023-03-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
West Henrietta, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2149-2021