# FDA recall Z-1352-2021

> **Clerio Vision** · Class II · device recall initiated 2021-02-16.

## 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

- **Recall number:** Z-1352-2021
- **Recalling firm:** Clerio Vision
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1352-2021. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1352-2021. Source: US FDA. Licensed CC0.

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