Tear Rewetter

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

Generic Name

Accessories, soft lens products

PMA Number

P800065 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001

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See all devices from Advanced Medical Optics, Inc. →

• What is the Tear Rewetter designed to address for contact lens wearers and how does it work?

  The Tear Rewetter is specifically designed to maintain hydration and comfort for individuals who wear soft contact lenses. It functions as a single-use solution to replenish the tear film on the eye, helping to reduce dryness and irritation that often occurs with prolonged lens wear. By restoring moisture, it aims to improve overall comfort and reduce discomfort associated with dry eyes.

• Is the Tear Rewetter intended for reuse, or is it meant to be used only once?

  The Tear Rewetter is explicitly supplied as a single-use solution. This design ensures sterility and efficacy for one application only, preventing contamination from repeated use. Each package is meant to be opened and used once before discarding.

• How should the Tear Rewetter be stored to maintain its sterility and effectiveness?

  The Tear Rewetter is packaged in a sterile form, so it must be stored according to the manufacturer’s instructions to preserve both sterility and efficacy. This typically involves keeping it in a cool, dry place, away from direct sunlight or extreme temperatures, and ensuring the seal remains intact until use.

• What regulatory pathway was followed for the approval of the Tear Rewetter, and what class does it fall under?

  The Tear Rewetter underwent FDA Premarket Approval (PMA) with the approval number P800065. It is classified under device class II and is regulated under the FDA’s PMA pathway, which requires rigorous review to ensure safety and effectiveness. The product is also listed under the generic name ‘Accessories, soft lens products’ and falls under the product code LPN.