The Amo Ophthalmic Surgical System

• • Terminated Z-1702-2008 FDA Unclassified (pre-2012) ·initiated 2 Apr 2008

  AMO initiated this field correction event after becoming aware of a trend in complaints associated with AMO Vitrectomy Cutter used in conjunction with the AMO WHITESTAR SIGNATURE Phacoemulsification System. The physician may be unable to make a cut during cataract surgery.

510(k) Number

K060366 ↗

FDA Product Code

HQC

Device Class

Class II

Regulation

21 CFR Part 886.4670

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

• 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. →