System 3 Wetting in Eye Comfort Drops

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

Accessories, soft lens products

PMA Number

P870029 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S007 (Normal 180 Day Track)

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See all devices from Advanced Medical Optics, Inc. →

• Are these drops intended for use with any specific type of contact lens, and how should they be applied?

  These drops are specifically formulated for use with soft contact lenses only. They are designed to be applied directly to the eye or the surface of the lens to provide lubrication and hydration, helping to relieve dryness and discomfort during wear.

• Are the System 3 Wetting in Eye Comfort Drops single-use, and if so, how are they packaged?

  Yes, the drops are single-use, meaning each application comes from a new, unopened unit. While the exact packaging details aren’t specified, they are supplied as drops intended for direct application, ensuring sterility and hygiene for each use.

• What regulatory pathway was followed for approval, and what does that mean for clinical use?

  The product was approved through the FDA Premarket Approval (PMA) process, specifically under PMA number P870029. This means the device underwent rigorous review to ensure safety and effectiveness for its intended use—providing lubrication and hydration for soft contact lens wearers—before being authorized for clinical application.

• Are these drops preserved, and if not, what does that imply for storage or handling?

  The drops are non-preserved, meaning they do not contain preservatives like benzalkonium chloride. This formulation is ideal for sensitive eyes but requires careful handling to prevent contamination, as there are no preservatives to inhibit microbial growth. Storage instructions aren’t detailed, but typical guidance for non-preserved ophthalmic solutions would emphasize keeping them in a clean, sealed environment until use.