ACUVUE (senofilcon A) Soft Contact Lens Multifocal
by Johnson & Johnson Vision Care, Inc. 510(k)
Active
510(k) K200243
Overview
This device is a Soft Contact Lens, Daily Wear, Multifocal (FDA nomenclature), designed to correct refractive ametropia (myopia and hyperopia) and presbyopia in phakic individuals with non-diseased eyes. Manufactured from senofilcon A material, it provides optical correction for near and distance vision in a single lens.
The ACUVUE (senofilcon A) Soft Contact Lens Multifocal is intended for daily wear and is supplied as a single-use product. It is classified as a Class II medical device under FDA regulations (886.5925) and has received FDA 510(k) clearance (K200243). No MRI safety or reusable specifications are noted in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK200243 | Date17 Mar 2020 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LPL
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5925
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Johnson & Johnson Vision Care, Inc.
Questions
What types of vision issues does the ACUVUE (senofilcon A) Soft Contact Lens Multifocal correct, and how does it differ from single-vision lenses?
The ACUVUE (senofilcon A) Soft Contact Lens Multifocal is designed to correct both myopia (nearsightedness) and hyperopia (farsightedness), while also addressing presbyopia—the age-related loss of near vision. Unlike single-vision lenses, which provide correction for one distance (near or far), this multifocal lens offers optical correction for both near and distance vision in a single lens, allowing users to see clearly at multiple focal points without switching lenses.
Is this lens intended for daily wear only, or can it be worn overnight?
The ACUVUE (senofilcon A) Soft Contact Lens Multifocal is explicitly designed for daily wear only, meaning it is not approved for extended or overnight use. The label and regulatory data emphasize its single-use nature, so it should be removed and discarded after each wear to maintain safety and hygiene.
How is the ACUVUE (senofilcon A) Soft Contact Lens Multifocal supplied, and is it reusable?
This lens is supplied as a single-use product, meaning each lens is intended for one-time wear and should not be reused. The packaging is designed for individual lenses, ensuring sterility and preventing cross-contamination between uses. Reuse is not supported by the manufacturer or regulatory clearance.
What material is the lens made from, and does this affect its suitability for sensitive eyes?
The lens is manufactured from senofilcon A, a silicone hydrogel material known for its high oxygen permeability, which supports healthy corneal oxygenation even during extended wear (though this specific model is not approved for overnight use). This material is often recommended for users with dry eyes or those seeking comfort, as it balances moisture retention with breathability.
Are there multiple sizes or models available, or is this a one-size-fits-all lens?
The ACUVUE (senofilcon A) Soft Contact Lens Multifocal comes in multiple sizes and models, as indicated by the extensive list of FEI numbers (Foreign Entity Identification) in the regulatory data. These numbers correspond to different lens designs, powers, and base curves tailored to various prescriptions and eye shapes. Buyers should consult the manufacturer’s sizing guides or optometrist recommendations to select the appropriate model for their needs.