Device recall
Z-1338-2022: RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS…
FDA device recall · Class II · Rayner Intraocular Lenses Ltd
Key facts
| Recall number (Z-number) | Z-1338-2022 |
|---|---|
| Recall event | 90301 |
| Product | RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and (2) Inner primary device packaging labeled as Rayner RayOne EMV US, REF RAO200E, SE… |
| Product code | HQL |
| Recalling firm | Rayner Intraocular Lenses Ltd |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P060011, P060011S025 |
| FEI number | 3012304651 |
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