Device recall
Z-1352-2021: EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear…
FDA device recall · Class II · Clerio Vision
Key facts
| Recall number (Z-number) | Z-1352-2021 |
|---|---|
| Recall event | 87421 |
| 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… |
| Product code | LPL |
| Recalling firm | Clerio Vision |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 5, 2023 |
| FEI number | 3005184723 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database