Device recall
Z-2982-2018: Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc…
FDA device recall · Class III · Alden Optical
Key facts
| Recall number (Z-number) | Z-2982-2018 |
|---|---|
| Recall event | 80800 |
| Product | Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC TPC (Toric Peripheral Curve) Zen RC FT (Front Toric Optics) Catalog Number: AOZNT Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the correction of refractive… |
| Product code | HQD |
| Recalling firm | Alden Optical |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 28, 2020 |
| 510(k) numbers | K033594 |
| FEI number | 1315522 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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