Sorbic Acid Preserved Daily Cleaner

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

Generic Name

Accessories, soft lens products

PMA Number

P850076 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S007 (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 Sorbic Acid Preserved Daily Cleaner primarily used for and how does it differ from other soft lens solutions?

  The Sorbic Acid Preserved Daily Cleaner is specifically designed as a preservative solution for daily cleaning and maintenance of soft contact lenses. It incorporates sorbic acid, which helps extend shelf life and maintain hygiene, distinguishing it from non-preserved alternatives. This solution is classified under ophthalmic soft lens accessories and is intended for single-use per lens, ensuring optimal cleanliness and safety for lens wearers.

• Is this product sterile and meant for single-use only? If so, how should it be handled to maintain sterility?

  Yes, the Sorbic Acid Preserved Daily Cleaner is supplied as a sterile solution and is intended for single-use per lens. To maintain sterility, avoid contaminating the solution by using clean hands or a sterile applicator when dispensing. Once opened, the solution should be used immediately and discarded after one use to prevent microbial growth or cross-contamination.

• What regulatory approval does this product hold, and how does that affect its use in clinical settings?

  This product holds FDA Premarket Approval (PMA) under PMA number P850076, with a product code of LPN. This approval ensures it meets stringent regulatory standards for safety and effectiveness as a soft lens accessory. Clinicians and users can rely on this approval when incorporating the solution into their daily contact lens care routines, as it confirms compliance with FDA requirements for ophthalmic products.

• Are there multiple sizes or models of this product, or is it available in a single formulation?

  The provided data does not specify distinct sizes or models beyond its classification as a preservative solution for soft contact lenses. It is formulated as a single-use sterile solution, and the registration numbers indicate multiple lot or batch identifiers rather than variations in size or formulation. Users should refer to the labeling for specific usage instructions, as the product is standardized for daily cleaning and maintenance.

• How should this product be stored, and what are the key considerations for shelf life and handling?

  While the exact storage instructions are not detailed in the provided data, preservative solutions like this typically require storage in a cool, dry place away from direct sunlight. The supplement notes a labeling change related to shelf life, so users should follow the expiration date printed on the packaging. Proper sealing of the container after each use and keeping it away from contaminants are critical to maintaining its efficacy and safety.