FDA Device recall Z-1753-2020
RaySert PLUS RSP01
- FDA Device
- Class II
- ongoing
- Published 2020-04-29
On 2020-04-29 the FDA classified a Class II recall of RaySert PLUS RSP01 by Rayner Intraocular Lenses, citing 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 numb….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1753-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-03-17 |
| Published | 2020-04-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Rayner Intraocular Lenses |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | LOT K030. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1753-2020%22
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