Class II — Rayner Intraocular Lenses Limited
| Recalling firm | Rayner Intraocular Lenses Limited |
|---|---|
| Registered facility | Rayner Intraocular Lenses Limited (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| 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. |
| Quantity | 2425 Units. |
| Distribution | US nationwide distribution in the states of OH, FL, GA, MD, SC, NJ, PR, IN, ID and MN. |
| Initiated | 2020-03-17 |
| Classified | 2020-04-21 |
| Recall number | Z-1753-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Rayner Intraocular Lenses Limited (Z-1753-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85270/
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