ORA System with VerifEye — Class II medical device recall Z-3050-2017
Terminated recall by Alcon Research, Ltd., reported 2017-08-30, distributed nationwide. Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This i
| Recall number | Z-3050-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, Ltd., Fort Worth, TX, United States |
| Recall initiated | 2017-06-30 |
| Classified | 2017-08-21 |
| Reported by FDA | 2017-08-30 |
| Terminated | 2019-08-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BE, BR, CA, CN, CO, ES, FR, GB, IN, JP, MX, NL, PA, PT, RO, TH |
| Quantity | 367 units |
| Reason classes | software |
| Serial numbers | C0002, C2006, C2020, C2026, C2054, C3009R, C3010R, C3024, C3036, C3066, C3067, C3085R, C3090, C3093, C3108, C3136, C3153, C4001, C4003, C4005, C4006, C4007, C4009, C4010, C4011 and 341 more |
| Model numbers | 8065998300 |
Product
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
Reason for recall
Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that results in the lens coefficients for an IOL model being downloaded from the Alcon server in an incorrect order.
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-3050-2017. 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.