Device recall
Z-0985-2018: Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product…
FDA device recall · Class II · Alden Optical
Key facts
| Recall number (Z-number) | Z-0985-2018 |
|---|---|
| Recall event | 79377 |
| Product | Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia). The lens may be worn by… |
| Product code | LPL |
| Recalling firm | Alden Optical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 19, 2018 |
| 510(k) numbers | K091327 |
| 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