FDAFDA · Food and drugs·Recall number Z-0469-2024
EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
Published December 13, 2023 · Recall initiated: September 29, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Their is a potential that intraocular implant devices may not meet specifications.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Staar Surgical Company
- Distributor
- 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
- Lot
- Serial Number/UDI: S1723954/(01)00841542122061(11)221101(17)240930(21)S1723954; S1723955/(01)00841542122061(11)221101(17)240930(21)S1723955;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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