Staar Surgical Company recalls EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
- Recall date
- September 29, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0467-2024
- 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_13.7.Phakic Intraocular lens.
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