Toric and Optima (Hefilcon B) Contact Lenses
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- NATUREVUE CONTACT LENSE FDA PMA
- Generic Name
- Lenses, soft contact, daily wear FDA PMA
Identifiers
- PMA Number
- N17676 FDA PMA
- FDA Product Code
- LPL FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 886.5925 FDA PMA
- Regulation Number
- 886.5925 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S001 FDA PMA
These are soft contact lenses designed for daily wear, intended to correct refractive errors, including astigmatism (toric lenses) and presbyopia (Optima lenses). Manufactured from Hefilcon B silicone hydrogel material, they provide extended comfort and oxygen permeability for prolonged use.
The lenses are supplied as single-use, non-sterile products and are regulated under FDA Premarket Approval (PMA N17676). They are classified as Class II devices under the FDA’s product code LPL and are intended for ophthalmic use. Storage instructions and specific sizes are detailed in the accompanying packaging.
Frequently asked questions
Are these contact lenses designed for overnight wear, or are they strictly for daily use during waking hours?
These lenses are explicitly designed for daily wear only, meaning they are intended to be worn during waking hours and removed before sleep. The description specifies they are not approved for continuous or extended overnight wear, so adherence to daily wear guidelines is essential for safety and comfort.
How are these lenses supplied, and do they require any special handling before use?
The lenses are supplied as single-use, non-sterile products. Since they are non-sterile, they should be handled with clean hands and stored according to the packaging instructions until use. Each lens is intended for one-time wear only, so no reprocessing or reuse is permitted.
What material are these lenses made from, and how does that affect their performance?
These lenses are manufactured from Hefilcon B silicone hydrogel material, which provides extended comfort and enhanced oxygen permeability for prolonged daily wear. This material is designed to balance moisture retention with breathability, making them suitable for users who require both clarity and comfort throughout the day.
Are there different sizes or models available, and how do I determine the correct fit?
While the exact sizes or models are detailed in the accompanying packaging, the lenses are categorized under FDA product code LPL and are available in multiple variations (as indicated by the registration numbers). To determine the correct fit, a prescription from an eye care professional should be followed, as they will specify the appropriate diopter power, curvature, and diameter for your eyes.
What regulatory pathway was followed for approval, and how does that affect their use?
These lenses were approved through the FDA Premarket Approval (PMA) process, specifically under PMA number N17676. This pathway ensures rigorous evaluation of safety and effectiveness for devices classified as Class II, which includes soft contact lenses. The approval confirms they meet FDA standards for daily wear use, but they remain subject to professional fitting and follow-up care as prescribed by an eye care provider.
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 | N17676 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA PMA N17676 23 fields · synced Sep 18, 2026