[Recalled] EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens. — Their is a potential that intraocular implant devices may not meet specificatio… | FDA 2023-09-29
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens. |
|---|---|
| Brand / manufacturer | Staar Surgical Company |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0471-2024 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 29 September 2023 |
| EAN / barcode | 00841542114141 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Their is a potential that intraocular implant devices may not meet specifications.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Staar Surgical Company
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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