Soft-Care Disinfection Regimen for Contact Lenses

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

Generic Name

Accessories, soft lens products

PMA Number

P790029 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S009

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See all devices from Advanced Medical Optics, Inc. →

• What is the Soft-Care Disinfection Regimen for Contact Lenses used for, and where can it be applied?

  The Soft-Care Disinfection Regimen is designed specifically for disinfecting and storing soft contact lenses to maintain hygiene and prevent microbial contamination. It is intended for use in both home settings by consumers and clinical environments, such as eye care offices. The regimen follows ophthalmic standards to ensure safe and effective lens care.

• Is the Soft-Care Disinfection Regimen for single-use or reusable, and how should it be stored?

  The Soft-Care Disinfection Regimen is supplied as a single-use system per lens care cycle, meaning each use requires a fresh application. Storage is straightforward—it only requires standard room temperature and protection from direct sunlight, so no special conditions are needed.

• What regulatory pathway does the Soft-Care Disinfection Regimen follow, and what does that mean for its use?

  The Soft-Care Disinfection Regimen is regulated under the FDA’s Premarket Approval (PMA) process as a Class II device, with the specific regulation number 886.5928. This means it has undergone rigorous review to ensure safety and effectiveness for its intended use as a disinfection and storage solution for soft contact lenses, allowing for both home and clinical application.

• Does the Soft-Care Disinfection Regimen come in different sizes or models, and how would I identify the correct one for my needs?

  The Soft-Care Disinfection Regimen is classified under accessories for soft lens products, but the provided data does not specify distinct sizes or models beyond its core function as a multi-component disinfection system. Since it is designed for general use with soft contact lenses, it should be compatible with most standard soft lens types. If unsure, consulting with an eye care professional or referring to the manufacturer’s guidelines would ensure proper selection.