Non-Preserved Saline Solution

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

Accessories, soft lens products

PMA Number

P850025 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001 (Normal 180 Day Track)

• Bandage

  Class I

  FDA 510(k) K761093 Active Cleared 6 Jan 1977

• Charter Wetting Solution for Hard Contact Lenses

  Unclassified

  FDA 510(k) K862952 Active Cleared 25 Sep 1986

• Sterile Saline Solution

  Class I

  FDA 510(k) K843797 Active Cleared 18 Jan 1985

• Charter Laboratories Inc. Lens Lubricant

  Unclassified

  FDA 510(k) K863974 Active Cleared 10 Nov 1986

• Sterile Water

  Not classified

  FDA 510(k) K843796 Active Cleared 10 Dec 1984

• Charter Hard Contact Lens Cleaning Solution

  Unclassified

  FDA 510(k) K865111 Active Cleared 20 Jan 1987

See all devices from Paco Pharmaceutical Services, Inc. →

• What is the primary purpose of this saline solution in ophthalmic care, and why is it labeled as non-preserved?

  This saline solution is specifically designed for rinsing, wetting, or storing soft contact lenses to help maintain their cleanliness and hydration. It is labeled as non-preserved because it contains no chemical preservatives, which makes it ideal for sensitive eyes or those prone to irritation from preservatives found in other lens care solutions.

• Is this product intended for single-use or repeated use, and how is it packaged?

  The product is supplied as a sterile, single-use solution, meaning each package is intended for one-time use only. It is packaged for direct use by patients or professionals in ophthalmic settings, ensuring sterility and convenience.

• What regulatory pathway was followed for this device, and what does that mean for its use?

  This device was approved through the FDA’s Premarket Approval (PMA) process, specifically under PMA number P850025. This pathway ensures that the device has been thoroughly evaluated for safety and effectiveness before being authorized for use in ophthalmic settings, particularly for soft contact lens care.

• Are there any specific storage instructions or considerations for this saline solution?

  While the data does not explicitly detail storage instructions, as a sterile, single-use product, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow the manufacturer’s guidelines on the packaging to maintain sterility and product integrity.