Lensrins(R) Sterile Preserved Saline Solution

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

Trade Name

Lensrins(R) Sterile Preserved Saline Soln

Generic Name

Accessories, soft lens products

PMA Number

P810029 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001

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• What is the primary purpose of the LENSRINS® Sterile Preserved Saline Solution, and how does it differ from regular saline solutions?

  The LENSRINS® Sterile Preserved Saline Solution is specifically designed for use with soft contact lenses to maintain lens hygiene and integrity between wearings. Unlike regular saline solutions, it is sterile, preserved, and formulated as a storage and cleaning solution tailored for ophthalmic use. This ensures lenses remain clean and safe for repeated use without compromising their condition.

• Is the LENSRINS® solution intended for single-use or repeated use with the same contact lenses?

  The LENSRINS® Sterile Preserved Saline Solution is supplied in a sterile form for single-use applications. While it is intended to maintain lens hygiene between wearings, each bottle is meant to be used once to preserve sterility and prevent contamination, adhering to best practices for contact lens care.

• How should the LENSRINS® solution be stored, and what precautions should be taken to maintain its efficacy?

  Since the LENSRINS® Sterile Preserved Saline Solution is sterile, it must be stored and handled according to sterile medical practice guidelines. This includes keeping the solution in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring the seal remains intact until first use. Proper storage ensures the solution remains effective for its intended purpose.

• What regulatory pathway does the LENSRINS® Sterile Preserved Saline Solution follow, and what does this mean for its use?

  The LENSRINS® Sterile Preserved Saline Solution is regulated under the FDA Premarket Approval (PMA) pathway with PMA number P810029, classified as a Class 2 device. This means it has undergone rigorous review to ensure safety and effectiveness for its intended use as a storage and cleaning solution for soft contact lenses, providing assurance of its quality and compliance with ophthalmic standards.