Alcon Monarch III — Class II medical device recall Z-0978-2017
Terminated recall by Alcon Research, Ltd., reported 2017-01-18. The intraocular lens could become lodged within the cartridge
| Recall number | Z-0978-2017 |
|---|---|
| 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 | 2016-09-05 |
| Classified | 2017-01-09 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2017-02-10 |
| Countries outside the US | MX |
| Quantity | 1,130 units |
| Lot numbers | 32395407 |
| Model numbers | 8065977762 |
Product
Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal
Reason for recall
The intraocular lens could become lodged within the cartridge
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-0978-2017. 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.