Monarch III IOL Delivery System, Monarch III C Cartridge, Monarch III Handpiece (H4)

• • Terminated Z-0978-2017 FDA Class II ·initiated 5 Sep 2016

  The intraocular lens could become lodged within the cartridge

510(k) Number

K112977 ↗

FDA Product Code

MSS

Device Class

Class I

Regulation

21 CFR Part 886.4300

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Alcon Multi-Purpose Disinfecting Solution Open recall

  Class II

  FDA 510(k) K050729 Active Cleared 14 Sep 2005

• Ladarwave Customcornea Wavefront System

  Class I

  FDA 510(k) K062930 Active Cleared 8 Nov 2006

• Clearcut S Safety Knife Open recall

  Class I

  FDA 510(k) K110166 Active Cleared 20 May 2011

• CENTURION Vision System (Active SentryTM)

  Class II

  FDA 510(k) K161794 Active Cleared 14 Apr 2017

• Monarch II IOL Delivery System

  Class I

  FDA 510(k) K001157 Active Cleared 27 Jun 2000

• Wavelight FS200 Laser System Model: FS200

  Class II

  FDA 510(k) K101006 Active Cleared 21 Oct 2010

See all devices from Alcon Research, Ltd. →