FDA Device recall Z-1352-2021
EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity i…
- FDA Device
- Class II
- terminated
- Published 2021-04-14
On 2021-04-14 the FDA classified a Class II recall of EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity i… by Clerio Vision, citing contact lenses may be mislabeled with the incorrect lens power.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1352-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-16 |
| Published | 2021-04-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Clerio Vision |
| Distribution | US |
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
Contact lenses may be mislabeled with the incorrect lens power.
Identifiers
| upc | 675506700657 |
|---|---|
| code_info | Lot Number: 0114511565, UPC Code: 675506700657 (6 pack), 675506668650 (individual) |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1352-2021%22
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