Device recall
Z-0044-2012: AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT…
FDA device recall · Class I · CooperVision Inc.
Key facts
| Recall number (Z-number) | Z-0044-2012 |
|---|---|
| Recall event | 60008 |
| Product | AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES FOR ASTIGMATISM, CooperVision, Scottsville, NY 14546 USA; Juana Diaz, PR 00795 USA; Hamble SO31, 4RF, UK; Device Listing # D033736. Product Usage: Indicated for the correction of ametropia (myopia or hyperopia… |
| Product code | LPL |
| Recalling firm | CooperVision Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 6, 2019 |
| 510(k) numbers | K071736 |
| FEI number | 3005724763 |
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