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Bausch & Lomb Sterile Preserved Saline Soln

FDA PMA

Class II (US FDA PMA)

PMA P800024

by Bausch & Lomb, Inc.

Identity

Trade Name
BAUSCH & LOMB STERILE PRESERVED SALINE SOLN FDA PMA
Generic Name
Accessories, soft lens products FDA PMA

Identifiers

PMA Number
P800024 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
S012 FDA PMA

This device is a sterile preserved saline solution designed for ophthalmic use, classified under accessories for soft lens products. It serves as a cleaning, rinsing, and storing solution for soft contact lenses, maintaining lens hygiene and comfort during wear.

Supplied as a single-use solution, it is intended for use in clinical and home settings by ophthalmic professionals and patients. The product is regulated under FDA PMA (Premarket Approval) with classification as a Class II device (886.5928). Storage and handling must adhere to sterile conditions to ensure efficacy and safety.

Frequently asked questions

What is the primary purpose of the Bausch & Lomb Sterile Preserved Saline Solution and how is it used in clinical settings?

The Bausch & Lomb Sterile Preserved Saline Solution is designed specifically for ophthalmic use as a cleaning, rinsing, and storing solution for soft contact lenses. It helps maintain lens hygiene and comfort during wear by ensuring proper care in both clinical and home settings. Its sterile formulation is essential for preventing contamination, making it suitable for use by ophthalmic professionals and patients alike.

Is this saline solution intended for single-use or can it be reused? How does this affect its storage and handling?

This saline solution is explicitly labeled as a single-use product. Because it is sterile and preserved, reusing it could compromise sterility and increase the risk of infection or irritation. Therefore, it must be stored in a sterile environment, sealed until use, and discarded immediately after opening to ensure safety and efficacy.

What regulatory pathway does this device follow, and what does that mean for its use in healthcare settings?

This device follows the FDA Premarket Approval (PMA) pathway, classified as a Class II medical device under product code LPN. The PMA process ensures that the device meets stringent safety and effectiveness standards before approval. Clinically, this means it has undergone rigorous evaluation for ophthalmic use as a saline solution for soft contact lenses, providing assurance of its reliability and compliance with regulatory requirements.

Are there different sizes or models available for this saline solution, and how would I identify the correct one for my needs?

The provided data does not specify distinct sizes or models beyond the single-use formulation for ophthalmic use. Since it is a standardized saline solution for soft contact lenses, the product is likely supplied in consistent, single-dose containers. Always verify the packaging and labeling to confirm compatibility with your specific contact lens type or care regimen, as variations in lens material or care instructions may influence the choice of solution.

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. Sources consulted: Bausch + Lomb Official Home Page, Anmelden | Bausch Germany MC Site, Startseite | Bausch + Lomb, Produkte | Bausch + Lomb, Bausch & Lomb – Wikipedia

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Bausch & Lomb, Inc.

Sources (1)

  • FDA PMA P800024 23 fields · synced Sep 18, 2026