Chlorhexidine-Thimerosal-Edetate Disodium Disinfec

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

Generic Name

Accessories, soft lens products

PMA Number

P850012 ↗

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 disinfectant solution in ophthalmic care?

  This solution is specifically designed as a disinfectant for soft contact lenses to reduce microbial contamination and maintain lens hygiene. It helps ensure lenses remain clean and safe for use in ophthalmic settings.

• Is this product intended for reuse or is it meant for single-use only?

  The product is supplied as a sterile solution intended for single-use applications in ophthalmic settings. It is not designed for reuse, as single-use aligns with its purpose of maintaining lens hygiene and preventing microbial contamination.

• How is this disinfectant regulated by the FDA, and what does that mean for its use?

  This disinfectant is regulated under FDA Premarket Approval (PMA) with PMA number P850012, meaning it has undergone rigorous review to ensure safety and effectiveness. It falls under 21 CFR 886.5928 and is classified as an ophthalmic accessory for soft lens products, confirming its intended use in professional eye care settings.

• What types of contact lenses is this solution compatible with, and how should it be stored?

  While the data does not specify exact lens materials, this disinfectant is explicitly designed for soft contact lenses as an ophthalmic accessory. Storage instructions are not detailed, but since it is a sterile solution, it should be kept in a clean, dry place away from direct sunlight and extreme temperatures to preserve its efficacy and sterility.