Soft Mate Weekly Cleaning Solution

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

Generic Name

Accessories, soft lens products

PMA Number

P810017 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S004

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See all devices from Advanced Medical Optics, Inc. →

• What is the primary purpose of the SOFT MATE Weekly Cleaning Solution and how does it differ from daily lens care solutions?

  The SOFT MATE Weekly Cleaning Solution is specifically designed for the maintenance of soft contact lenses to remove protein deposits during routine care. Unlike daily lens care solutions, which are typically used for cleaning and disinfecting lenses every day, this solution is intended for weekly use to address accumulated protein buildup, ensuring lenses remain clean and comfortable for extended wear.

• Is the SOFT MATE Weekly Cleaning Solution sterile, and how should it be handled to ensure proper use?

  The SOFT MATE Weekly Cleaning Solution is not sterile, so it must be handled in accordance with standard ophthalmic cleaning protocols. Since it is supplied as a premixed liquid for either single-use or reusable contact lens cleaning, users should follow manufacturer guidelines for storage and application to avoid contamination, particularly when used for reusable lenses.

• What regulatory pathway was followed for the approval of this device, and what does that mean for its use in clinical settings?

  The SOFT MATE Weekly Cleaning Solution was authorized under the FDA’s Premarket Approval (PMA) pathway, specifically PMA number P810017 with supplement S003. This means the device underwent rigorous review by the FDA to ensure safety and effectiveness for its intended use in ophthalmic applications, particularly for removing protein deposits from soft contact lenses during routine maintenance.

• Can this solution be used with all types of soft contact lenses, or are there specific lens materials it is compatible with?

  The SOFT MATE Weekly Cleaning Solution is intended for use with soft contact lenses as part of routine maintenance, but compatibility depends on the lens material and manufacturer recommendations. While the solution is designed for general use in ophthalmic applications, users should always refer to the specific lens manufacturer’s instructions to confirm suitability, as some lens materials may require alternative cleaning solutions.

• How is the SOFT MATE Weekly Cleaning Solution supplied, and what considerations should be made for storage?

  The solution is supplied as a premixed liquid in a single-use or reusable format, meaning it can be used either per application or refilled for multiple uses (following proper cleaning protocols). Storage should adhere to standard ophthalmic practices—keep the solution in a clean, sealed container away from direct sunlight or extreme temperatures to maintain efficacy and prevent contamination.