FDA recall Z-1352-2021

Clerio Vision · Class II · device

Product

EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.

Reason for recall

Contact lenses may be mislabeled with the incorrect lens power.

Distribution

Worldwide distribution - US Nationwide distribution in the states of Illinois and Missouri, and the countries of Denmark, Germany, The Netherlands, Switzerland.

Key facts

Status
Terminated
Initiation date
2021-02-16
Report date
2021-04-14
Termination date
2023-07-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sarasota, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1352-2021