Sovereign High Vacuum Pack, Sovereign Compact High Vacuum Pack

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

510(k) Number

K050648 ↗

FDA Product Code

HQC

Device Class

Class II

Regulation

21 CFR Part 886.4670

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• 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

• Complete Blink-N-Clean Lens Drops

  Class II

  FDA 510(k) K040839 Active Cleared 19 Oct 2004

See all devices from Advanced Medical Optics, Inc. →

• What is the Sovereign High Vacuum Pack used for?

  The Sovereign High Vacuum Pack is a disposable, sterile vacuum system designed exclusively for use with phacoemulsification machines during cataract surgery. Its filter-protected flow restriction orifice minimizes vacuum surges in the aspiration line, improving precision and stability throughout the procedure. This ensures smoother surgical conditions when removing the lens and fragments during phacoemulsification.

• Are the Sovereign High Vacuum Pack and Sovereign Compact High Vacuum Pack single-use or reusable?

  Both the Sovereign High Vacuum Pack and Sovereign Compact High Vacuum Pack are single-use devices. They are sterile upon packaging and intended for one-time use only to maintain surgical safety and prevent cross-contamination. Reuse is not recommended or approved by the manufacturer.

• What are the key specifications or distinguishing features of these vacuum packs?

  The primary distinguishing feature of these packs is their filter-protected flow restriction orifice, which stabilizes vacuum performance during phacoemulsification. This design reduces sudden pressure fluctuations in the aspiration line, contributing to smoother surgical workflows. They are also sterile, disposable units and are not MRI-compatible. The packs are classified under FDA category HQC (ophthalmic phacoemulsification units) and hold FDA 510(k) clearance as substantially equivalent devices.

• How should the Sovereign High Vacuum Pack be stored?

  The Sovereign High Vacuum Pack must be stored in accordance with sterile medical device protocols to preserve sterility. This includes keeping the packaging intact, storing in a clean, dry environment away from direct sunlight or extreme temperatures, and ensuring the device is not exposed to moisture or contamination. Always follow the manufacturer’s instructions for storage to maintain device integrity and sterility.

• Are there different models or sizes available for the Sovereign High Vacuum Pack?

  The Sovereign High Vacuum Pack and Sovereign Compact High Vacuum Pack are two distinct models offered by Advanced Medical Optics. While both serve the same primary function, the Compact variant may offer slight design or compatibility differences optimized for specific phacoemulsification systems. The exact specifications (e.g., flow rates, orifice sizes) are standardized for their intended use with Sovereign or Sovereign Compact phacoemulsification machines. For precise compatibility, refer to the manufacturer’s documentation or consult technical support.