C-flex 570C +19 — Class II medical device recall Z-3282-2018
Terminated recall by Rayner Intraocular Lenses Limited, reported 2018-10-10. Firm become aware of reports of post-operative refractive errors following implantation of lenses.
| Recall number | Z-3282-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Rayner Intraocular Lenses Limited, Worthing, United Kingdom |
| Recall initiated | 2018-08-09 |
| Classified | 2018-09-28 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2020-11-24 |
| Quantity | 49 |
| Lot numbers | 017100825 |
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
Reason for recall
Firm become aware of reports of post-operative refractive errors following implantation of lenses.
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-3282-2018. 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.