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Sensitive Eyes Cleaning/Disinfecting Solution

FDA PMA

Class II (US FDA PMA)

PMA P860023

by Bausch & Lomb, Inc.

Identity

Trade Name
SENSITIVE EYES CLEANING/DISINFECTING SOLUTION FDA PMA
Generic Name
Accessories, soft lens products FDA PMA

Identifiers

PMA Number
P860023 FDA PMA
FDA Product Code
LPN FDA PMA

Classification

Device Class
Class II FDA PMA
Legislation / Framework
21 CFR Part 886.5928 FDA PMA
Regulation Number
886.5928 FDA PMA
Advisory Committee
Ophthalmic FDA PMA
FDA Decision
APPR Approved FDA PMA
PMA Supplement
S001 (Normal 180 Day Track) FDA PMA

This device is classified as an Accessory, Soft Lens Products under the FDA nomenclature, specifically designed for cleaning and disinfecting soft contact lenses. It provides a gentle yet effective solution to remove debris, proteins, and contaminants from lens surfaces while ensuring microbial safety for daily wear or extended use.

The solution is supplied as a sterile, single-use or multi-use formulation (as indicated by the labeling) and is intended for use in ophthalmic settings. It adheres to FDA-authorized standards under PMA P860023 and regulation number 886.5928, with labeling changes tracked under supplement S001. Compliance with device class 2 requirements ensures its suitability for soft lens care, with no MRI safety restrictions noted.

Frequently asked questions

What types of contact lenses is this solution designed to clean and disinfect, and how does it differ from other lens care products?

This Sensitive Eyes Cleaning/Disinfecting Solution is specifically formulated for soft contact lenses, including daily wear and extended wear types. Unlike some multi-purpose solutions, it is designed to gently yet effectively remove debris, proteins, and contaminants while ensuring microbial safety. Its classification as an Accessory, Soft Lens Products under FDA nomenclature distinguishes it from rigid gas-permeable or hard lens care solutions, which require different formulations.

Is this solution single-use or reusable, and how should it be stored to maintain its effectiveness?

The solution is available in both single-use and multi-use formulations, as indicated on the labeling. For multi-use versions, it must be stored in a sterile, sealed container away from direct sunlight and extreme temperatures. Single-use versions should be discarded after one application to prevent contamination. Proper storage ensures the solution remains effective for cleaning and disinfecting lenses as intended.

What regulatory pathway does this device follow, and how does that affect its use in clinical settings?

This solution follows the FDA Premarket Approval (PMA) pathway, authorized under PMA P860023 and regulated under 21 CFR 886.5928. Its classification as a Class II device ensures it meets stringent standards for soft lens care, including microbial safety and efficacy. Clinicians can rely on its compliance with FDA requirements, though they should always follow the manufacturer’s instructions for proper use, as the PMA approval does not alter clinical decision-making.

Are there any special handling instructions for this solution, particularly regarding sterility or compatibility with lens materials?

The solution is sterile upon packaging, which is critical for preventing microbial contamination of lenses. It is formulated to be gentle yet effective for soft contact lenses, ensuring compatibility with common lens materials like silicone hydrogel and hydrogel. However, users should avoid mixing it with other solutions or additives, as this could compromise sterility or performance. Always refer to the labeling for specific instructions on handling and storage.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Bausch & Lomb, Inc.

Sources (1)

  • FDA PMA P860023 23 fields · synced Sep 18, 2026