Paragon Z CRT and Paragon Z CRT Dual Axis (Tisilfocon A) Contact Lenses
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY FDA PMA
- Generic Name
- Lens, contact, orthokeratology, overnight FDA PMA
Identifiers
- PMA Number
- P050031 FDA PMA
- FDA Product Code
- NUU FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 886.5916 FDA PMA
- Regulation Number
- 886.5916 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Paragon Z CRT and Paragon Z CRT Dual Axis (Tisilfocon A) Contact Lenses are rigid gas permeable contact lenses designed for contact lens corneal refractive therapy (orthokeratology). These lenses are intended to temporarily reduce myopia up to 6.00 diopters in non-diseased eyes, with accommodation for astigmatism up to 1.75 diopters. The lenses reshape the cornea overnight to provide daytime visual correction without the need for glasses or daytime contact lens wear.
These lenses are supplied in sterile packaging and are intended for overnight wear as part of a prescribed corneal refractive therapy program. They must be disinfected using only a chemical disinfection system and are not reusable. The lenses are classified as Class III medical devices under FDA regulations and are authorized under PMA number P050031. Proper storage and adherence to the prescribed wear schedule are essential to maintain therapeutic effectiveness and avoid visual fluctuations or unintended refractive changes.
Frequently asked questions
What is the primary purpose of the Paragon Z CRT and Paragon Z CRT Dual Axis contact lenses, and how do they differ from traditional contact lenses?
The Paragon Z CRT and Paragon Z CRT Dual Axis lenses are designed specifically for contact lens corneal refractive therapy (orthokeratology). Unlike traditional contact lenses that provide daytime vision correction, these lenses reshape the cornea overnight to temporarily reduce myopia (nearsightedness) up to 6.00 diopters, with accommodation for astigmatism up to 1.75 diopters. This allows for clear daytime vision without the need for glasses or daytime contact lenses. The Dual Axis version is tailored for eyes with astigmatism, offering a more customized fit for better refractive correction.
Are these lenses reusable, and if not, how should they be handled to maintain sterility and effectiveness?
No, these lenses are not reusable and are intended for single-use per prescribed wear schedule. They are supplied in sterile packaging and must be disinfected using only a chemical disinfection system between uses. Proper storage and adherence to the prescribed overnight wear schedule are critical to maintain therapeutic effectiveness and avoid unintended refractive changes or visual fluctuations.
What is the regulatory pathway for these lenses, and what does that mean for clinicians or patients considering them?
The Paragon Z CRT and Paragon Z CRT Dual Axis lenses are classified as Class III medical devices under FDA regulations and are authorized through a Premarket Approval (PMA) process (PMA #P050031). This means they undergo rigorous clinical evaluation to ensure safety and effectiveness for their intended use—temporary myopia reduction via overnight corneal reshaping. Clinicians must follow the prescribed fitting program and wear schedule to achieve and maintain the intended refractive correction.
How do I determine if a patient is a candidate for these lenses, and what limitations should be considered?
These lenses are indicated for non-diseased eyes with myopia up to 6.00 diopters and astigmatism up to 1.75 diopters. They are not intended for diseased eyes or patients with conditions that could interfere with corneal reshaping. Continuous overnight wear on a prescribed schedule is required to maintain myopia reduction—failure to follow this schedule can lead to visual fluctuations, unintended refractive changes, or impaired daytime activities (e.g., night driving). A comprehensive eye exam and professional fitting are essential before use.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P050031 | Class III | Active |
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Manufacturer
- Manufacturer
- Coopervision Inc.
- FDA Applicant
- CooperVision, Inc.
Sources (1)
- FDA PMA P050031 24 fields · synced Sep 18, 2026