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B&L Sensitive Eyes Saline/Cleaning Solution

FDA PMA

Class II (US FDA PMA)

PMA P850036

by Bausch & Lomb, Inc.

Identity

Trade Name
B&L SENSITIVE EYES(TM) SALINE/CLEANING SOLUTION FDA PMA
Generic Name
Accessories, soft lens products FDA PMA

Identifiers

PMA Number
P850036 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 Accessories, Soft Lens Products and serves as a sterile ophthalmic solution designed for cleaning and rinsing soft contact lenses. It provides a saline-based formulation to maintain lens hygiene and comfort while ensuring compatibility with soft lens materials.

The solution is supplied as a single-use sterile product, intended for use in ophthalmic settings such as eye care clinics or home environments. It adheres to FDA regulations under PMA (Premarket Approval) with approval number P850036, ensuring compliance with 21 CFR 886.5928. No MRI safety or reusable specifications are indicated.

Frequently asked questions

What is the primary purpose of the B&L Sensitive Eyes™ Saline/Cleaning Solution, and where can it be used?

The B&L Sensitive Eyes™ Saline/Cleaning Solution is designed specifically for cleaning and rinsing soft contact lenses to maintain lens hygiene and comfort. It is formulated as a saline-based solution to ensure compatibility with soft lens materials. Due to its sterile formulation, it is suitable for use in both ophthalmic clinic settings and home environments.

Is this solution single-use or reusable, and what does that mean for its sterility?

The B&L Sensitive Eyes™ Saline/Cleaning Solution is explicitly labeled as a single-use sterile product. This means each unit is intended for one-time use only, ensuring sterility and reducing the risk of contamination between uses.

What regulatory pathway does this device follow, and what does that imply about its safety and compliance?

This device follows the FDA’s Premarket Approval (PMA) pathway under approval number P850036, adhering to 21 CFR 886.5928. This regulatory route ensures rigorous review and compliance with strict safety and effectiveness standards for ophthalmic accessories, particularly those involving soft contact lenses.

Are there different sizes or models of this solution available, and how would I identify them?

The device data lists multiple FEI numbers (e.g., 3006140792, 3012236936) under the product code LPN, which may correspond to different package sizes or variants. However, the core formulation remains consistent as a sterile saline/cleaning solution for soft lenses. For exact sizing or model distinctions, refer to the packaging or manufacturer’s documentation, as these identifiers are administrative rather than clinical.

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 P850036 23 fields · synced Sep 18, 2026