Class II — Rayner Intraocular Lenses Ltd
| Recalling firm | Rayner Intraocular Lenses Limited |
|---|---|
| Registered facility | Rayner Intraocular Lenses Limited (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The outer package is mislabeled and the package contains a different IOL strength. |
| Product | RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and (2) Inner primary device packaging labeled as Rayner RayOne EMV US, REF RAO200E, SE: +21.00D, Sph: +21.00D. |
| Quantity | 162 IOLs |
| Distribution | US Nationwide distribution in the states of AZ, CA, FL, GA, IN, MI, MN, MO, ND, NJ, OK, TN, and TX. |
| Initiated | 2022-05-13 |
| Classified | 2022-07-06 |
| Recall number | Z-1338-2022 |
| 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 Ltd (Z-1338-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90301/
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