Device recall
Z-0134-2015: ProClear Toric contact lenses are made from a material containing 62% water and…
FDA device recall · Class III · Cooper Vision Caribbean Corp.
Key facts
| Recall number (Z-number) | Z-0134-2015 |
|---|---|
| Recall event | 69160 |
| Product | ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling. |
| Product code | LPL |
| Recalling firm | Cooper Vision Caribbean Corp. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 10, 2015 |
| 510(k) numbers | K123202 |
| FEI number | 3002911336 |
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