Hydron(Tm) Saline System (135 & 250mg)

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

Generic Name

Accessories, soft lens products

PMA Number

P810047 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S001

• Sovereign High Vacuum Pack, Sovereign Compact High Vacuum Pack

  Class II

  FDA 510(k) K050648 Active Cleared 5 Apr 2005

• The Amo Ophthalmic Surgical System

  Class II

  FDA 510(k) K060366 Active Cleared 7 Apr 2006

• Lens Plus Rewetting Drops

  Class II

  FDA 510(k) K042562 Active Cleared 29 Jul 2005

• Vitrectomy Cutter and Accessories

  Class II

  FDA 510(k) K081681 Active Cleared 8 Oct 2008

• Blink Cl Lubricant Eye Drops

  Class II

  FDA 510(k) K032030 Active Cleared 25 Sep 2003

• One Series Ultra Cartridge, Model 1VIPR30

  Class I

  FDA 510(k) K081545 Active Cleared 2 Oct 2008

See all devices from Advanced Medical Optics, Inc. →

• What specific ophthalmic procedures is the Hydron Saline System designed to assist with during contact lens handling?

  The Hydron Saline System is designed as an irrigation accessory for soft contact lens procedures, specifically to facilitate cleaning, rinsing, or hydration of lens materials. It is not intended for surgical use but rather as part of the lens preparation workflow in clinical or patient care settings.

• Are there different versions of the Hydron Saline System, and if so, how do they differ?

  Yes, the Hydron Saline System comes in two versions distinguished by concentration: 135 mg and 250 mg. The numerical difference refers to the formulation strength, which may influence the hydration or cleaning efficacy for specific lens materials, though the core purpose remains the same—assisting in soft lens handling.

• How should the Hydron Saline System be stored to maintain its sterility and usability?

  Since the Hydron Saline System is intended for sterile use, it must be stored and handled according to standard sterile medical device protocols. This includes keeping it in its original packaging until use and ensuring the environment remains uncontaminated to preserve sterility.

• Is the Hydron Saline System reusable, or is it designed for single-use only?

  The Hydron Saline System is explicitly labeled as a single-use device, meaning it should not be reused after one application. This designation aligns with sterile medical device practices to prevent cross-contamination and ensure patient safety.

• What regulatory pathway does the Hydron Saline System follow, and how does that affect its use?

  The Hydron Saline System is authorized under FDA Premarket Approval (PMA) with PMA number P810047, indicating it underwent rigorous review for safety and effectiveness. Clinicians and buyers can rely on this approval to confirm its compliance with FDA standards for ophthalmic accessories used in soft lens handling.