RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing… — Class II medical device recall Z-1338-2022
Ongoing recall by Rayner Intraocular Lenses Ltd, reported 2022-07-13, distributed nationwide. The outer package is mislabeled and the package contains a different IOL strength.
| Recall number | Z-1338-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Rayner Intraocular Lenses Ltd, Worthing, N/A, United Kingdom |
| Recall initiated | 2022-05-13 |
| Classified | 2022-07-06 |
| Reported by FDA | 2022-07-13 |
| Distributed | Nationwide (US) |
| Quantity | 162 iols |
| Reason classes | labeling, potency |
| UPC / GTIN / UDI-DI | 05029867006685, 05029867006722 |
| Lot numbers | 012183745, 012183845 |
| Serial numbers | 01-06, 24-45, 48-53, 58-60, 61-65, 68-81 |
| Model numbers | RAO200E |
| Expiration dates | 2024-01-17 |
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.
Reason for recall
The outer package is mislabeled and the package contains a different IOL strength.
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-1338-2022. 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.