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Euclid Orthokeratology (Oprifocon A and Tisilfocon A) Contact Lenses for Overnight Wear

FDA PMA

Class III (US FDA PMA)

PMA P040029

by Euclid Vision Corporation

Identity

Trade Name
Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact FDA PMA
Generic Name
Lens, contact, orthokeratology, overnight FDA PMA

Identifiers

PMA Number
P040029 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 Euclid Orthokeratology (Oprifocon A and Tisilfocon A) Contact Lenses are orthokeratology contact lenses designed to temporarily reduce myopic refractive error in non-diseased eyes. These lenses reshape the cornea during overnight wear to provide daytime visual correction, indicated for myopia up to 5.00 diopters with astigmatism up to 1.50 diopters.

These lenses are intended for overnight wear only and must be disinfected using a chemical disinfection system. They are supplied as single-use lenses and require continued overnight wear on a prescribed schedule to maintain myopia reduction. The lenses are classified as Class III devices under FDA regulations and are approved under PMA number P040029. Storage and handling must comply with manufacturer guidelines to ensure sterility and effectiveness.

Frequently asked questions

Are these lenses reusable, or are they meant to be used once and then discarded?

These lenses are supplied as single-use and are not designed for reuse. Each lens is intended for one overnight wear cycle, after which it must be discarded. This ensures sterility and effectiveness, as required by the manufacturer’s guidelines.

What is the maximum level of myopia and astigmatism these lenses can correct, and how does that affect daily use?

The lenses are indicated for myopia correction up to 5.00 diopters with astigmatism up to 1.50 diopters. However, to maintain the intended myopic reduction, they must be worn overnight on a prescribed schedule. Skipping wear can lead to visual fluctuations, reduced daytime correction, and potential issues like difficulty night driving.

How should these lenses be cleaned and stored to ensure they remain effective?

These lenses must be disinfected using a chemical disinfection system only—no other cleaning methods are approved. After use, they must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Improper storage or cleaning could compromise the lens’s ability to reshape the cornea effectively.

Are these lenses suitable for patients with pre-existing eye conditions, or are they only for healthy eyes?

These lenses are explicitly indicated for non-diseased eyes only. They are not approved for use in patients with existing eye conditions, infections, or corneal abnormalities. Always verify patient eligibility with an eye care professional before prescribing.

What regulatory pathway was followed for approval, and what class does this device fall under?

The lenses were approved through the FDA’s Premarket Approval (PMA) process under PMA number P040029. They are classified as Class III devices, which requires rigorous clinical evidence to demonstrate safety and effectiveness for their intended use in reshaping the cornea to reduce myopia.

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

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Euclid Vision Corporation

Sources (1)

  • FDA PMA P040029 24 fields · synced Oct 6, 2026