Soft Mate Comfort Drops
by Advanced Medical Optics, Inc.
PMA P800018
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP800018 | Date25 Jan 1983 | 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- Withdrawn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
- 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
- S002
Overview
AI-generated summary, 18 Sep 2026
Soft Mate Comfort Drops are accessories for soft lens products designed to provide comfort for contact lens wearers. These drops are formulated to alleviate dryness and irritation associated with contact lens use.
The device is supplied as a sterile ophthalmic product and is intended for single-use application. Soft Mate Comfort Drops are regulated as a Class II medical device with FDA PMA approval number P800018, and are manufactured by Advanced Medical Optics, Inc. in Irvine, California.
Other devices from Advanced Medical Optics, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are Soft Mate Comfort Drops intended for reuse or are they single-use only?
Soft Mate Comfort Drops are designed for single-use application only. The product is supplied as a sterile ophthalmic solution, which means each bottle is meant to be used once and then discarded to maintain sterility and prevent contamination.
How should I store Soft Mate Comfort Drops to ensure they remain effective?
Since Soft Mate Comfort Drops are a sterile ophthalmic product, they should be stored in a cool, dry place away from direct sunlight and extreme temperatures. Always check the packaging for any specific storage instructions, but generally, keeping them in their original, unopened container until use is recommended.
What is the primary purpose of Soft Mate Comfort Drops, and who would benefit from using them?
Soft Mate Comfort Drops are formulated to alleviate dryness and irritation commonly experienced by contact lens wearers. They are specifically designed as an accessory for soft lens products, providing relief for those who may feel discomfort due to prolonged wear or environmental factors like dry air.
Are there different sizes or models of Soft Mate Comfort Drops, or is it available in a single formulation?
The provided data does not specify multiple sizes or models of Soft Mate Comfort Drops. It is described as a single formulation intended for general use with soft contact lenses to relieve dryness and irritation. If variations exist, they would likely be indicated on the product labeling or packaging.