Artisan Myopia
by Ophtec BV
PMA P030028
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP030028 | Date10 Sep 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Artisan (Model 206 and 204) Phakic Intraocular Lens (Piol) Verisyse (VRSM5US and VRSM6US) Phakic Intraocular Lens (Piol)
- Generic Name
- Lens, intraocular, phakic
- PMA Number
- FDA Product Code
- MTA
- Device Class
- Class III
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Artisan Phakic Intraocular Lens is a phakic intraocular lens designed for the reduction or elimination of myopia in adults. It is intended for use in patients with myopia ranging from -5 to -20 diopters, with ≤2.5 diopters of astigmatism, and an anterior chamber depth ≥3.2 mm. The device is classified as a Class III medical device under the FDA’s nomenclature for intraocular lenses.
This lens is supplied sterile and intended for single-use implantation in the eye. It is distributed by Advance Medical Optics and must be handled under aseptic conditions. The device is approved for distribution under FDA PMA (P030028) and is available in specific model variants (Models 206, 204, VRSM5US, VRSM6US). No MRI safety information is specified, and storage conditions are not detailed in the regulatory data.
Other devices from Ophtec BV
Questions
AI-generated answers, 18 Sep 2026
What specific diopter ranges and astigmatism limits does the Artisan Myopia lens address in patients?
The Artisan Myopia lens is designed for adults with myopia ranging from -5 to -20 diopters, with up to 2.5 diopters of astigmatism at the spectacle plane. It requires an anterior chamber depth of at least 3.2 mm for implantation.
Are there multiple model variants of the Artisan Myopia lens, and how are they differentiated?
Yes, the Artisan Myopia lens comes in four model variants: Models 206 and 204 (referred to as the Artisan PIOL), and VRSM5US and VRSM6US (referred to as the Verisyse PIOL). These variants are differentiated by their specific design and intended use within the approved diopter range.
How should the Artisan Myopia lens be handled and stored, and is it reusable?
The Artisan Myopia lens is supplied sterile and intended for **single-use** implantation only. It must be handled under aseptic conditions, though specific storage conditions (e.g., temperature, humidity) are not detailed in the regulatory data. Reuse is not permitted.
What regulatory pathway was followed for approval, and which manufacturer/distributor is responsible for distribution?
The Artisan Myopia lens received FDA approval via a **Premarket Approval (PMA)** application (PMA #P030028), a rigorous pathway for Class III devices. The manufacturer is Ophtec BV (Groningen, Netherlands), while distribution in the U.S. is managed by Advance Medical Optics.
What stability criteria must a patient meet before being considered for the Artisan Myopia lens?
Patients must demonstrate **refractive stability** for at least six months prior to implantation, defined as a spherical equivalent change of ≤0.50 diopters. This ensures the myopia is stable before lens placement.