Clerio Vision — Class II medical device recall Z-0808-2021
Terminated recall by Clerio Vision, reported 2021-01-20, distributed nationwide. 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
| Recall number | Z-0808-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clerio Vision, Sarasota, FL, United States |
| Recall initiated | 2020-12-10 |
| Classified | 2021-01-08 |
| Reported by FDA | 2021-01-20 |
| Terminated | 2023-07-05 |
| Distributed | Nationwide (US) |
| Quantity | 208 lenses |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00675506803334, 00675506804478 |
| Lot numbers | 2026/09, 3100246509 |
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
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-0808-2021. 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.