Surgical Image Guidance Functionality — Class II medical device recall Z-2412-2024
Ongoing recall by Alcon Research LLC, reported 2024-07-24, distributed nationwide. After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a
| Recall number | Z-2412-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research LLC, Fort Worth, TX, United States |
| Recall initiated | 2024-05-23 |
| Classified | 2024-07-18 |
| Reported by FDA | 2024-07-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, FR, JP |
| Quantity | 230 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00380650003997 |
| Serial numbers | 004-0680001, 004-0680002, 004-0680003, 004-0680004, 004-0680007, 004-0680008, 004-0680017, 004-0680026, 004-0680036, 004-0680047, 004-0680048, 004-0680086, 004-0680090, 004-0680092, 004-0680096, 004-0680100, 004-0680107, 004-0680112, 004-0680120, 004-0680127, 004-0680131, 004-0680134, 004-0680140, 004-0680152, 004-0680153 and 205 more |
| Model numbers | 8065000399 |
Product
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
Reason for recall
After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range indicator will display incorrectly, which could result in incorrect placement of toric IOL axis, which could cause astigmatic error under/over correction resulting in decreased uncorrected visual acuity.
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-2412-2024. 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.