EXTREME H2O 59% — Class II medical device recall Z-1352-2021
Terminated recall by Clerio Vision, reported 2021-04-14, distributed nationwide. Contact lenses may be mislabeled with the incorrect lens power.
| Recall number | Z-1352-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clerio Vision, Sarasota, FL, United States |
| Recall initiated | 2021-02-16 |
| Classified | 2021-04-05 |
| Reported by FDA | 2021-04-14 |
| Terminated | 2023-07-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, DE, DK, NL |
| Quantity | 153 lenses |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00675506668650, 00675506700657 |
| Lot numbers | 0114511565 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1352-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.