Class II — Staar Surgical Co.
| Recalling firm | STAAR SURGICAL Company |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses). |
| Product | STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses. |
| Quantity | 2,612 units |
| Distribution | US |
| Initiated | 2016-05-02 |
| Classified | 2016-06-14 |
| Terminated | 2016-11-15 |
| Recall number | Z-1964-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Staar Surgical Co. (Z-1964-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74067/
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