Visian Implantable Collamer Lens For Myopia (micl)
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- VISIAN ICL (IMPLANTABLE COLLAMER LENS) FDA PMA
- Generic Name
- Lens, intraocular, phakic FDA PMA
Identifiers
- PMA Number
- P030016 FDA PMA
- FDA Product Code
- MTA FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Visian Implantable Collamer Lens for Myopia (MICL) is a phakic intraocular lens designed to correct myopia. Classified as a lens, intraocular, phakic, it is intended for implantation in the eye to address moderate to high myopia, including astigmatism, while preserving the natural lens. The device is constructed from Collamer, a biocompatible material combining soft plastic and collagen, and is approved for use in adults aged 21–45 with specific refractive criteria.
The MICL is supplied sterile and intended for single-use implantation in the anterior chamber of the eye. Models vary by diopter strength and optical zone diameter, with anterior chamber depth requirements of 3.00 mm or greater. Authorized under FDA PMA (P030016), it adheres to regulatory standards for phakic intraocular lenses and is distributed as a Class III device. Storage and handling follow sterile medical device protocols to ensure integrity prior to use.
Frequently asked questions
What age range is the Visian Implantable Collamer Lens (MICL) approved for use in patients with myopia?
The Visian MICL is approved for adults aged 21 to 45. This age range is specified in the FDA-approved indications to ensure patient safety and optimal outcomes for moderate to high myopia correction while preserving the natural lens.
How is the Visian MICL supplied, and is it intended for single-use or reuse?
The Visian MICL is supplied sterile and explicitly intended for single-use implantation in the anterior chamber of the eye. This aligns with standard sterile medical device protocols to maintain integrity and prevent cross-contamination.
What are the key diopter ranges and optical zone specifications for the Visian MICL models?
The Visian MICL comes in four FDA-approved models with varying diopter strengths and optical zone diameters: MICL12.1, MICL12.6, MICL13.2, and MICL13.7. These models address myopia correction from -3.0 to -20.0 diopters (with ≤2.5D astigmatism) while requiring an anterior chamber depth of ≥3.00 mm for proper placement.
What storage and handling precautions should be followed for the Visian MICL before implantation?
The Visian MICL must be stored and handled according to sterile medical device protocols to preserve its integrity. Since it is supplied sterile and single-use, it should remain in its original packaging until immediately before use, following manufacturer guidelines to prevent contamination or damage.
What is the regulatory pathway for the Visian MICL, and how does it classify the device?
The Visian MICL is classified as a Class III device under FDA regulations and was approved via a Premarket Approval (PMA) application (P030016). This pathway is required for high-risk devices like phakic intraocular lenses, ensuring rigorous evaluation of safety and effectiveness before market authorization.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Visian® ICL™ - Staar Surgical, PDF Visian ICLTM (Implantable Collamer Lens) - Staar, PDF Visian ICL - Staar, PDF Visian ICL - edfu.staar.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P030016 | Class III | Active |
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Manufacturer
- Manufacturer
- Staar Surgical Company
Sources (1)
- FDA PMA P030016 24 fields · synced Sep 20, 2026