Isotonic Sterile Unpreserved Saline Solution

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

Generic Name

Accessories, soft lens products

PMA Number

P860066 ↗

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)

• Vis-Sol Sterile Preserved Saline Solution

  Class II

  FDA PMA P870017 Active Approved 19 Oct 1987

• What is the primary purpose of the Isotonic Sterile Unpreserved Saline Solution, and how does it differ from preserved saline solutions?

  The Isotonic Sterile Unpreserved Saline Solution is designed specifically for maintaining soft contact lenses by providing a non-preserved, sterile saline medium. Unlike preserved saline solutions, which contain chemical additives like preservatives, this solution avoids such additives to reduce potential irritation or sensitivity, ensuring a cleaner and more hydrated lens environment.

• Is this solution intended for reuse, or is it meant for single-use only? How should it be stored?

  This solution is supplied in sterile, single-use packaging, meaning each unit is intended for one-time use only. To maintain sterility and efficacy, it should be stored in a cool, dry place, away from direct sunlight, and kept within the expiration date printed on the packaging.

• What regulatory pathway was followed for the approval of this product, and what does that mean for its use?

  The Isotonic Sterile Unpreserved Saline Solution received FDA Premarket Approval (PMA) under PMA number P860066, with a supplement (S002) addressing design or specification changes. This approval indicates that the product has undergone rigorous evaluation to ensure safety and effectiveness as an ophthalmic accessory for soft contact lens care, adhering to strict regulatory standards.

• Are there different sizes or models available for this saline solution, and how would I know which one to choose?

  The provided data lists multiple FEI numbers (e.g., 3006140792, 3012236936) under the registration numbers, which may correspond to different lot or batch identifiers rather than distinct sizes or models. Since the product is classified under the same generic name and product code (LPN) for soft lens accessories, it is likely supplied in a standardized form. Confirming the exact packaging size or variant would require checking the product labeling or contacting the manufacturer.