Lens Plus Sterile Buffered Saline Solution
by Advanced Medical Optics, Inc.
PMA N18020
Active
Valid until
No expiry
FDA recalls
None foundDocuments
PMA N18020
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberN18020 | Date5 Aug 1980 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Lens Plus Sterile Saline Solution (Buffered)
- Trade Name
- Allergan Preserved Saline Solution
- Generic Name
- Accessories, soft lens products
- PMA Number
- FDA Product Code
- LPN
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5928
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S004
Overview
AI-generated summary, 18 Sep 2026
This device is a sterile buffered saline solution designed for use with soft contact lenses. It is classified as an ophthalmic accessory under the nomenclature for soft lens products, providing a compatible solution for lens care and maintenance to ensure ocular hygiene and lens integrity.
The solution is supplied in sterile, single-use packaging and is intended for ophthalmic use only. It adheres to FDA-authorized standards under PMA N18020 and regulation 886.5928, with no MRI safety restrictions noted. Available in standard ophthalmic packaging sizes, it requires proper storage to maintain sterility and should be used in accordance with clinical protocols for soft lens care.
Other devices from Advanced Medical Optics, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of this saline solution in soft contact lens care, and how does it differ from regular saline?
This ALLERGAN PRESERVED SALINE SOLUTION is a sterile, buffered saline specifically formulated for soft contact lens maintenance, ensuring ocular hygiene and lens integrity by providing a compatible environment. Unlike regular saline, it is preserved (to extend shelf life) and ophthalmically optimized to reduce irritation while cleaning and storing lenses. It is not intended for general wound irrigation or non-lens applications.
Is this solution single-use, and if so, how should it be stored to maintain sterility?
Yes, this solution is supplied in sterile, single-use packaging, meaning each unit is intended for one-time use only. To preserve sterility, store it unopened in a cool, dry place (away from direct sunlight or extreme temperatures) until ready for use. Once opened, use immediately and discard any remaining solution to prevent contamination.
What regulatory pathway was followed for this device, and does it have any MRI safety restrictions?
This device was approved via the FDA’s Premarket Approval (PMA) pathway under PMA N18020 and regulation 886.5928, classified as a Class II ophthalmic accessory for soft lens products. There are no MRI safety restrictions noted in the documentation, meaning it is safe to use in MRI environments as long as standard protocols for saline solutions are followed.
Are there different sizes or models available for this saline solution, and how would I identify the correct one for my practice?
This solution is supplied in standard ophthalmic packaging sizes, but the exact variations (e.g., bottle sizes, dropper types) are not detailed in the provided data. Since it is genericly classified as