Class II — Staar Surgical Company
| 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 | Their is a potential that intraocular implant devices may not meet specifications. |
| Product | EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens. |
| Quantity | 1 UNIT |
| Distribution | US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None |
| Initiated | 2023-09-29 |
| Classified | 2023-12-01 |
| Recall number | Z-0468-2024 |
| 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 Company (Z-0468-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93312/
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