Optimum Infinite (Tisilfocon A) Orthokeratology Lenses II

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Lens, contact, orthokeratology, overnight

PMA Number

P240045 ↗

FDA Product Code

NUU

Device Class

Class III

Regulation

21 CFR Part 886.5916

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

• Contaflex 55 (Methafilcon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut)

  Class II

  FDA 510(k) K023989 Active Cleared 26 Feb 2003

• OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens

  Class II

  FDA 510(k) K180616 Active Cleared 25 Apr 2018

• Contaflex 38 (Polymacon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut)

  Class II

  FDA 510(k) K023987 Active Cleared 26 Feb 2003

• CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,

  Class II

  FDA 510(k) K150590 Active Cleared 10 Jul 2015

• Hyper GP (tisilfocon A) Daily Wear Contact Lens

  Class II

  FDA 510(k) K182304 Active Cleared 23 Nov 2018

• OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)

  Class II

  FDA 510(k) K160859 Active Cleared 13 Jul 2016

See all devices from Contamac, Ltd. →

• Are these lenses designed for continuous wear throughout the day, or are they meant to be worn only at night for vision correction?

  These lenses are specifically designed for overnight orthokeratology use only. They reshape the cornea while worn during sleep, allowing patients to achieve clear vision during waking hours without needing to wear contact lenses during the day. This makes them ideal for myopia management in eligible patients.

• How are the Optimum Infinite (tisilfocon A) Orthokeratology Lenses II supplied, and can they be reused?

  The lenses are supplied as either single-use or reusable, depending on the specific model and prescription. The decision to reuse should follow the manufacturer’s instructions to ensure safety and efficacy, as reuse is not universally applicable across all orthokeratology lenses. Always verify the supply type with the accompanying documentation.

• What storage and handling conditions are required for these lenses, and how should they be stored to maintain sterility or cleanliness?

  Storage and handling must adhere to sterile or clean conditions as outlined in the manufacturer’s instructions. Since these are medical-grade contact lenses, proper care—such as using approved solutions and avoiding contamination—is critical. The instructions provided with the lenses detail the exact storage requirements to preserve their integrity and safety.

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

  The Optimum Infinite (tisilfocon A) Orthokeratology Lenses II were approved under the FDA’s Premarket Approval (PMA) pathway, with approval number P240045. They are classified as Class III devices under regulation 886.5916, indicating they undergo stringent review due to their role in reshaping the cornea for vision correction.

• Are there different sizes or models available, and how do I determine which one is right for my patient?

  Multiple models exist, each corresponding to specific product codes (e.g., NUU) and prescriptions. The exact sizing and parameters are detailed in the associated product codes listed in the specifications. A certified eye care professional should select the appropriate model based on the patient’s corneal curvature, refractive error, and clinical needs, following the manufacturer’s guidelines.