Device recall
Z-1976-2011: SoftPerm (synergicon A) Daily Wear Contact Lenses, Rx Only, Sterile. Contents…
FDA device recall · Class II · CIBA Vision Puerto Rico, Inc.
Key facts
| Recall number (Z-number) | Z-1976-2011 |
|---|---|
| Recall event | 57714 |
| Product | SoftPerm (synergicon A) Daily Wear Contact Lenses, Rx Only, Sterile. Contents: One sterile contact lens, rigid center/soft hydrophilic skirt (25% water), in normal saline solution buffered with sodium bicarbonate. Ciba Vision Group, Duluth GA 30097 USA SoftPerm contact lenses are indicted for daily… |
| Product code | LPL |
| Recalling firm | CIBA Vision Puerto Rico, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 30, 2011 |
| PMA numbers | P840004 |
| FEI number | 2648694 |
At a glance
- None 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