Device recall
Z-2981-2018: Zenlens 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-2981-2018 |
|---|---|
| Recall event | 80800 |
| Product | Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenlens Toric-Zenlens FT + MV (Front Toric+Microvault); Zenlens TPC-(Toric Peripheral Curve); Zenlens TPC + FT- (Toric Peripheral Curve + FrontToric) Zenlens TPC + MV… |
| 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