Thimerosal Preserved Saline Solution

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

Generic Name

Accessories, soft lens products

PMA Number

P850047 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S004 (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 solution in contact lens care, and how does it differ from non-preserved saline solutions?

  This Thimerosal Preserved Saline Solution is designed specifically as a preservative for soft contact lenses, preventing microbial contamination and maintaining sterility during storage and handling. Unlike non-preserved saline solutions, it contains thimerosal, a mercury-based preservative, which extends shelf life by inhibiting bacterial and fungal growth. It is classified as an ophthalmic accessory under FDA Premarket Approval (PMA), ensuring its safety and efficacy for use with soft lens products.

• Is this solution intended for reuse, or is it meant to be used only once? How should it be stored?

  This solution is sterile and single-use only, meaning each unit should be discarded after one use to prevent contamination. Storage must follow sterile solution protocols—keep it in a cool, dry place away from direct sunlight and ensure the packaging remains intact until use. Improper storage could compromise sterility and effectiveness.

• What regulatory pathway does this device follow, and what does that mean for clinicians or buyers?

  This device follows the FDA Premarket Approval (PMA) pathway, indicated by PMA number P850047 and product code LPN. This means it underwent rigorous review by the FDA to ensure safety and effectiveness for its intended use as an ophthalmic accessory for soft lens products. Clinicians or buyers can trust that its design and manufacturing comply with strict regulatory standards, though they should always verify current compliance with the manufacturer.

• Are there different sizes or models of this solution, or is it supplied in a single formulation?

  The provided data does not specify multiple sizes or models—this solution is supplied as a single formulation under the trade name *Thimerosal Preserved Saline Solution*. However, the registration numbers and FEI numbers listed suggest it may be distributed in various packaging configurations (e.g., single-use vials or bottles) for different contact lens care routines. Buyers should confirm the exact packaging details with the manufacturer.