[Recalled] 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
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| 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. |
|---|---|
| Brand / manufacturer | Rayner Intraocular Lenses Limited |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1753-2020 |
| Country of notice | United Kingdom |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 17 March 2020 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was labeled with an expiry of 2015. In addition to having an expiry of 2015 the LOT number on the inner tray is identified as V001.
This Class II recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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