FDA Device Intelligence
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Lens, Intraocular, Phakic

FDA product code MTA · Class 3 · Unknown

432
Registered devices
21,997
Adverse events
8
Recalls
0
510(k) clearances

Devices with this code

EVO/EVO+VISIAN Implantable Collamer Lens — STAAR SURGICAL COMPANYEVO/EVO+VISIAN Implantable Collamer Lens — STAAR SURGICAL COMPANYVerisyse — Ophtec B.V.Visian ICL (Implantable Collamer Lens) — STAAR SURGICAL COMPANYEVO/EVO+VISIAN Implantable Collamer Lens — STAAR SURGICAL COMPANYEVO/EVO+VISIAN Implantable Collamer Lens — STAAR SURGICAL COMPANYEVO/EVO+VISIAN Implantable Collamer Lens — STAAR SURGICAL COMPANYEVO/EVO+VISIAN Implantable Collamer Lens — STAAR SURGICAL COMPANYArtisan — Ophtec B.V.EVO/EVO+VISIAN Implantable Collamer Lens — STAAR SURGICAL COMPANYEVO/EVO+VISIAN Implantable Collamer Lens — STAAR SURGICAL COMPANYVisian ICL (Implantable Collamer Lens) — STAAR SURGICAL COMPANYArtisan — Ophtec B.V.Visian ICL (Implantable Collamer Lens) — STAAR SURGICAL COMPANYEVO/EVO+VISIAN Implantable Collamer Lens — STAAR SURGICAL COMPANYEVO/EVO+VISIAN Implantable Collamer Lens — STAAR SURGICAL COMPANYEVO/EVO+VISIAN Implantable Collamer Lens — STAAR SURGICAL COMPANYEVO/EVO+VISIAN Implantable Collamer Lens — STAAR SURGICAL COMPANYEVO/EVO+VISIAN Implantable Collamer Lens — STAAR SURGICAL COMPANYEVO/EVO+VISIAN Implantable Collamer Lens — STAAR SURGICAL COMPANYVisian ICL (Implantable Collamer Lens) — STAAR SURGICAL COMPANYVerisyse — Ophtec B.V.Visian ICL (Implantable Collamer Lens) — STAAR SURGICAL COMPANYEVO/EVO+VISIAN Implantable Collamer Lens — STAAR SURGICAL COMPANY

Recent recalls

DateFirmReason
2026-04-20Staar Surgical AGDue to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
2023-09-29Staar Surgical CompanyTheir is a potential that intraocular implant devices may not meet specifications.
2023-09-29Staar Surgical CompanyTheir is a potential that intraocular implant devices may not meet specifications.
2023-09-29Staar Surgical CompanyTheir is a potential that intraocular implant devices may not meet specifications.
2023-09-29Staar Surgical CompanyTheir is a potential that intraocular implant devices may not meet specifications.
2023-09-29Staar Surgical CompanyTheir is a potential that intraocular implant devices may not meet specifications.
2023-09-29Staar Surgical CompanyTheir is a potential that intraocular implant devices may not meet specifications.
2023-09-29Staar Surgical CompanyTheir is a potential that intraocular implant devices may not meet specifications.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.