RaySert PLUS RSP01 — Class II medical device recall Z-1753-2020
Ongoing recall by Rayner Intraocular Lenses Limited, reported 2020-04-29, distributed nationwide. RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was labeled with an
| Recall number | Z-1753-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Rayner Intraocular Lenses Limited, Worthing, N/A, United Kingdom |
| Recall initiated | 2020-03-17 |
| Classified | 2020-04-21 |
| Reported by FDA | 2020-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 2,425 units |
| Reason classes | labeling |
| Lot numbers | 2024-01, K030 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1753-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.