FDA recall Z-0808-2021

Clerio Vision · Class II · device

Product

Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is 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

One lot of contact lenses labeled as BC MED, DIA 14.0 PWR -2.25 contained BC MED, DIA 14.0, PWR -3.75 contact lenses

Distribution

US Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2020-12-10
Report date
2021-01-20
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-0808-2021