Medical device recalls Moderate risk

Staar Surgical Company recalls EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.

Recall date
September 29, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0464-2024
FDA classification
Class II
Brand / firm
Staar Surgical Company
Sold / distributed
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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.

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