Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC ...

FDA Recall #Z-0808-2021 — Class II — December 10, 2020

Recall #Z-0808-2021 Date: December 10, 2020 Classification: Class II Status: Terminated

Product Description

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

Recalling Firm

Clerio Vision — Sarasota, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

208 lenses

Distribution

US Nationwide distribution.

Code Information

LOT 3100246509, EXP 2026/09

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated