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Soft Mate Comfort Drops

by Advanced Medical Optics, Inc.

PMA P800018

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P800018↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP800018 Date25 Jan 1983ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

See all devices from Advanced Medical Optics, Inc. →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.