STAAR AQ Cartridge-FP — Class II medical device recall Z-1964-2016
Terminated recall by Staar Surgical Co., reported 2016-06-22. The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Len
| Recall number | Z-1964-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Staar Surgical Co., Monrovia, CA, United States |
| Recall initiated | 2016-05-02 |
| Classified | 2016-06-14 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2016-11-15 |
| Quantity | 2,612 units |
| Reason classes | packaging, device malfunction |
Product
STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.
Reason for recall
The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular 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-1964-2016. 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.