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Monarch III IOL Delivery System

by Alcon Manufacturing, Ltd.

510(k) K063155

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK063155 Date27 Mar 2007ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0835-2025 FDA Class II initiated 13 Nov 2024

    Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
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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