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Adappte Artificial Tear

by Alcon Laboratories, Inc.

PMA N16993

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 N16993

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 NumberN16993 Date11 Aug 1981ApprovedStatusActive

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  • Withdrawn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
FDA applicant
Alcon Laboratories
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
S006

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.

The Adapte Artificial Tear is classified as a soft lens accessory under the nomenclature for ophthalmic devices. It is designed as a lubricating eye drop intended to relieve dryness and discomfort associated with ocular surface irritation, particularly in contact lens wearers or individuals with dry eye syndrome.

This sterile, single-use product is supplied in individual dropper bottles and is regulated under FDA PMA (Premarket Approval) with PMA number N16993. It is intended for use in ophthalmic settings and must be stored according to manufacturer instructions to maintain sterility and efficacy. The device adheres to regulatory standards for ophthalmic accessories, ensuring compliance with medical-grade specifications.

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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.

  • What is the primary purpose of the ADAPPTE Artificial Tear, and who is it most commonly used for?

    The ADAPPTE Artificial Tear is designed as a lubricating eye drop to relieve dryness and discomfort caused by ocular surface irritation. It is particularly beneficial for contact lens wearers or individuals suffering from dry eye syndrome, providing temporary relief from irritation and dryness.

  • How is the ADAPPTE Artificial Tear supplied, and is it reusable?

    The ADAPPTE Artificial Tear is supplied in individual, single-use dropper bottles. This design ensures sterility and prevents cross-contamination, making it unsuitable for reuse after opening.

  • What regulatory pathway does the ADAPPTE Artificial Tear follow, and what does this mean for its use?

    The ADAPPTE Artificial Tear follows the FDA Premarket Approval (PMA) pathway, indicated by PMA number N16993. This means the device has undergone rigorous review to ensure safety and effectiveness for its intended use in ophthalmic settings, adhering to strict medical-grade standards.

  • Are there specific storage instructions for the ADAPPTE Artificial Tear to maintain its efficacy?

    Yes, the ADAPPTE Artificial Tear must be stored according to the manufacturer’s instructions to preserve sterility and efficacy. While the exact storage conditions aren’t detailed here, typical sterile ophthalmic products like this are generally stored in a cool, dry place away from direct sunlight until use.