Device recall
Z-0350-2012: AVAIRA AQUAFORM Comfort Science enfilcon A Daily Wear SPHERE Soft Contact Lenses…
FDA device recall · Class I · Coopervision Inc.
Key facts
| Recall number (Z-number) | Z-0350-2012 |
|---|---|
| Recall event | 60434 |
| Product | AVAIRA AQUAFORM Comfort Science enfilcon A Daily Wear SPHERE Soft Contact Lenses (disposable), Rx only, STERILE --- CooperVision: Hamble, SO31 4RF, UK -- Scottsville, NY 14546 USA -- Juana Diaz, PR 00795 USA --- Device Listing # D033736. Packaged: 6 Soft Contact Lenses per unit carton or trial… |
| Product code | LPL |
| Recalling firm | Coopervision Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 24, 2018 |
| 510(k) numbers | K071736 |
| FEI number | 1000430350 |
At a glance
- 1–9 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