Sorbic Acid Preserved Lens Lubricant

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

Generic Name

Accessories, soft lens products

PMA Number

P850075 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S002 (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 lens lubricant, and how does the sorbic acid help?

  This lens lubricant is designed specifically to maintain moisture and comfort for soft contact lenses. The sorbic acid acts as a preservative, extending the shelf life of the solution while ensuring it remains compatible with the materials used in soft contact lenses. This helps prevent contamination and maintains the lubricant’s effectiveness over time.

• Is this product intended for single-use or repeated use, and how should it be stored?

  The product is supplied as a sterile, single-use solution, meaning each unit is meant for one-time use only. To maintain sterility and prevent contamination, it must be stored and handled according to sterile ophthalmic protocols, typically in a clean, dry environment away from direct sunlight or extreme temperatures.

• What regulatory pathway was followed for this device, and what class does it fall under?

  This lens lubricant was approved through the FDA’s Premarket Approval (PMA) process, with approval number P850075. It is classified as a Class II medical device under regulation number 886.5928, indicating it has a moderate level of risk and requires special controls to ensure safety and effectiveness.

• Are there different sizes or models available for this lubricant?

  The data provided does not specify distinct sizes or models beyond the single-use sterile formulation. However, the product code (LPN) and registration numbers suggest multiple lot or batch variations may exist for inventory or distribution purposes, but the core formulation remains consistent for soft contact lens use.

• How does this lubricant differ from non-preserved alternatives, and why is sorbic acid included?

  Unlike non-preserved lubricants, this product includes sorbic acid as a preservative, which helps inhibit microbial growth and extends the product’s shelf life without compromising compatibility with soft contact lens materials. This makes it ideal for maintaining lens hygiene and comfort over extended periods, particularly in multi-use scenarios where contamination risk is higher.