Vistakon Narafilcon A Soft Contact Lens

510(k) Number

K073485 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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• Are these contact lenses designed for extended wear, or are they meant for daily use only?

  The Vistakon Narafilcon A Soft Contact Lens is explicitly designed for daily wear only, not extended wear. This means they are intended to be worn during the day and removed at night, with each lens discarded after a single use. The single-use design eliminates the need for cleaning or disinfecting, simplifying patient care.

• What types of vision correction do these lenses address, and who is the intended user group?

  These lenses are designed for optical correction of distance and near vision, making them suitable for presbyopic individuals (those experiencing age-related difficulty focusing on close objects) and aphakic patients (those missing a natural lens due to surgery or injury). They are intended for use in non-diseased eyes, meaning they are not intended for treating ocular conditions but rather for routine vision correction.

• How are these lenses packaged and stored, and do they require any special handling?

  The Vistakon Narafilcon A lenses are supplied in sterile packaging, ensuring they are ready for immediate use without additional sterilization. Since they are single-use only, they must be discarded after removal. Proper storage involves keeping the lenses in their sealed packaging until use, away from direct sunlight, extreme temperatures, and moisture to maintain their integrity and sterility.

• Are there different designs available, and what features distinguish them?

  Yes, these lenses come in multiple designs to accommodate different vision needs: spherical, toric, multifocal, and toric-multifocal. Some variants also include a visibility-tinted option for easier handling, and all designs incorporate UV protection to shield the eyes from harmful ultraviolet rays. The internal wetting agent enhances comfort and moisture retention, which is particularly beneficial for extended daily wear.

• How is this device regulated, and what does that mean for clinicians or buyers?

  The Vistakon Narafilcon A Soft Contact Lens is classified as a Class II medical device under FDA regulations and was cleared through the 510(k) pathway, specifically under the Ophthalmic advisory committee (OP). This means it has undergone review by the FDA to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets safety and effectiveness standards for daily-wear soft contact lenses. Clinicians or buyers can rely on this regulatory clearance as confirmation of its compliance with FDA requirements for ophthalmic devices.