FDA-Device2023-12-13Class II

EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.

Staar Surgical Company
Hazard

Their is a potential that intraocular implant devices may not meet specifications.

Sold states
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
Affected count
3 units
Manufactured in
1911 Walker Ave, Monrovia, CA, United States
Products
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0470-2024

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