Class II — Staar Surgical AG
| 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 | Ongoing |
| Reason | Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal. |
| Product | EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 |
| Quantity | 7 |
| Distribution | International distribution to the countries of India, Iran, Korea, Saudi Arabia. |
| Initiated | 2026-01-21 |
| Classified | 2026-03-02 |
| Recall number | Z-1480-2026 |
| 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 AG (Z-1480-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98397/
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