SofLens Enzymatic Contact Lens Cleaner

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

Full name

Soflens(R) Enzymatic Contact Lens Cleaner

Generic Name

Accessories, soft lens products

PMA Number

N17654 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S014

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See all devices from Advanced Medical Optics, Inc. →

• What is the primary purpose of the SofLens Enzymatic Contact Lens Cleaner, and how does it differ from traditional contact lens cleaners?

  The SofLens Enzymatic Contact Lens Cleaner is specifically designed to use enzymatic action to remove protein deposits from soft contact lenses, helping maintain lens hygiene. Unlike traditional cleaners that rely on chemical solutions, this product employs enzymes to break down organic buildup, which can be particularly effective for lenses exposed to prolonged wear or high-protein environments like swimming or makeup use.

• Is the SofLens Enzymatic Contact Lens Cleaner intended for single-use or reusable applications, and how should it be stored?

  The SofLens Enzymatic Contact Lens Cleaner is available in both single-use and reusable formulations. Storage follows standard ophthalmic cleaning protocols to ensure efficacy and safety, meaning it should be kept in a clean, dry environment, away from direct sunlight or extreme temperatures, and sealed properly when not in use to maintain sterility and potency.

• What regulatory pathway was followed for the approval of this device, and what class does it fall under?

  The SofLens Enzymatic Contact Lens Cleaner was approved through the FDA’s Premarket Approval (PMA) process, with the approval number N17654. It is classified as a Class II medical device under FDA regulations, indicating it poses a moderate level of risk and requires special controls to ensure its safety and effectiveness.

• How is this product categorized in terms of medical specialty, and what types of settings would typically use it?

  This product falls under the ophthalmic medical specialty category, specifically designed for use in ophthalmic settings such as eye clinics, optometrist offices, and other healthcare environments where contact lens care is provided. Its enzymatic cleaning action makes it suitable for maintaining the hygiene of soft contact lenses in professional or clinical settings.