Monarch II IOL Delivery System

• • Terminated Z-2441-2008 FDA Unclassified (pre-2012) ·initiated 7 Jul 2008

  Delivery cartridge for implanting intraocular lenses is mislabeled and may result in complicated insertion and damage to the lens.

510(k) Number

K001157 ↗

FDA Product Code

KYB

Device Class

Class I

Regulation

21 CFR Part 886.4300

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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