Device recall
Z-0981-2018: NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The…
FDA device recall · Class II · Alden Optical
Key facts
| Recall number (Z-number) | Z-0981-2018 |
|---|---|
| Recall event | 79377 |
| Product | NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) in aphakic and not aphakic persons with otherwise nondiseased… |
| Product code | LPL |
| Recalling firm | Alden Optical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 19, 2018 |
| 510(k) numbers | K102557 |
| FEI number | 1315522 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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