SoftCon (Vifilcon A) Soft Contact Corrective Lens

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

Trade Name

Softcon Contact Lens

Generic Name

Lenses, soft contact, daily wear

PMA Number

N17554 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S003

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• What is the primary use of the SOFTCON (VIFILCON A) Soft Contact Corrective Lens, and who would benefit from it?

  The SOFTCON (VIFILCON A) Soft Contact Corrective Lens is designed for daily wear only to correct refractive errors in the eye, such as nearsightedness, farsightedness, or astigmatism. It is intended for patients who require vision correction and prefer the convenience of soft contact lenses over glasses or other corrective methods. Since it is not approved for overnight or extended wear, it is best suited for individuals who need daytime correction without the commitment of reusable lenses.

• Is this lens single-use or reusable, and how should it be handled after opening?

  The SOFTCON (VIFILCON A) Soft Contact Corrective Lens is explicitly labeled as a single-use, disposable product. Each lens is intended for one-time wear only and should not be reused. After opening the packaging, the lens should be handled with care to avoid contamination, and it must be discarded after use to maintain hygiene and safety standards.

• Are there specific storage instructions provided for this lens, and what should I consider when storing it?

  The provided data does not include detailed storage instructions for the SOFTCON (VIFILCON A) lens. However, as a single-use, disposable soft contact lens, it is typically recommended to store it in a clean, dry environment away from direct sunlight or extreme temperatures until use. Since it is not reusable, storage considerations are primarily relevant for unopened packaging. Always follow manufacturer guidelines if additional instructions are available.

• What regulatory pathway was followed for this device, and how does that affect its availability?

  The SOFTCON (VIFILCON A) Soft Contact Corrective Lens was approved through the FDA Premarket Approval (PMA) process, specifically under PMA number N17554. This pathway is required for Class II medical devices, ensuring rigorous evaluation of safety and effectiveness before market authorization. The device is classified under the product code LPL and is regulated as a Class II device under FDA regulations. Availability is governed by FDA compliance, meaning it must meet all approved specifications and labeling requirements.