Novalens (Rosilfocon A) Contact Lens

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Novalens (Rosilfocon a)

Generic Name

Lens, contact (other material) - daily

PMA Number

P890058 ↗

FDA Product Code

HQD

Device Class

Class II

Regulation

21 CFR Part 886.5916

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S008 (Normal 180 Day Track)

• Novalens/Novawet Perception and Vanguard

  Class II

  FDA 510(k) K942533 Active Cleared 5 Aug 1994

• What is the Novalens (Rosilfocon A) Contact Lens primarily used for in clinical practice?

  The Novalens (Rosilfocon A) Contact Lens is designed specifically for corneal refractive correction and vision enhancement in patients who require corrective eyewear. It is a daily-wear, single-use contact lens intended to improve vision clarity by reshaping the cornea, making it suitable for those seeking an alternative to traditional glasses or rigid gas-permeable lenses.

• How is the Novalens lens supplied, and what does this mean for its use?

  The Novalens lens is supplied as a sterile, single-use contact lens, meaning each lens is intended for one-time use only. This design ensures hygiene and reduces the risk of infection, as patients are not required to clean or disinfect the lens between uses. After removal, the lens should be discarded, and a new one inserted for the next wear.

• Are there multiple sizes or prescriptions available for the Novalens lens, and how are they identified?

  Yes, the Novalens lens is available in multiple sizes and prescriptions, each identified by unique FEI numbers (e.g., 3005994941, 3043365583, etc.). These numbers correspond to specific refractive corrections and lens parameters, allowing for customization to fit a patient’s prescription. Clinicians can select the appropriate FEI-numbered lens based on the patient’s vision needs.

• What regulatory pathway does the Novalens lens follow, and what does this imply for its use?

  The Novalens lens follows the FDA Premarket Approval (PMA) pathway, with PMA number P890058. This indicates that the device has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use—corneal refractive correction. The PMA classification also means it is classified as a Class II medical device under regulation 886.5916, which requires compliance with specific manufacturing and quality control standards to maintain its performance and sterility.

• How should the Novalens lens be stored, and what precautions should be taken?

  The Novalens lens must be stored and handled according to standard ophthalmic contact lens protocols to preserve sterility and performance. Since it is single-use, it should be kept in a sealed, sterile packaging until use. After opening, the lens should be inserted immediately, and any unused lenses should be discarded. Proper storage conditions (e.g., cool, dry, and protected from contamination) are essential to prevent degradation or contamination before use.