Vitrectomy Cutter and Accessories

• • Terminated Z-1893-2019 FDA Class II ·initiated 24 Sep 2018

  Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including corneal incision enlargement.

• • Terminated Z-2096-2017 FDA Class II ·initiated 30 Mar 2017

  Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package.

510(k) Number

K081681 ↗

FDA Product Code

MLZ

Device Class

Class II

Regulation

21 CFR Part 886.4150

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• 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

• 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. →