Device recall
Z-1753-2020: RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use…
FDA device recall · Class II · Rayner Intraocular Lenses Limited
Key facts
| Recall number (Z-number) | Z-1753-2020 |
|---|---|
| Recall event | 85270 |
| Product | RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labelling. |
| Product code | MSS |
| Recalling firm | Rayner Intraocular Lenses Limited |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K141091 |
| FEI number | 3012304651 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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