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 | Terminated |
| Reason | Firm become aware of reports of post-operative refractive errors following implantation of lenses. |
| Product | C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to be surgically implanted into the capsular bag of the human eye as a replacement for the crystalline lens following phacoemulsification |
| Quantity | 49 |
| Distribution | US in the states of MO |
| Initiated | 2018-08-09 |
| Classified | 2018-09-28 |
| Terminated | 2020-11-24 |
| Recall number | Z-3282-2018 |
| 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-3282-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80943/
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