MONARCH III IOL DELIVERY SYSTEM— 510(k) K063155

Clearance details

Applicant

Alcon Manufacturing, Ltd.

Product code

Code KYB

Device class

Class 1

Regulation

21 CFR 886.4300

Advisory panel

Ophthalmic

Date received

2006-10-17

Decision date

2007-03-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Fort Worth, TX, US

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• K120912 — INFINITI(R) VISION SYSTEM2012-06-15
• K112425 — INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE2011-11-21
• K101774 — MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)2011-10-13
• K101285 — CONSTELLATION VISION SYSTEM2010-11-12
• K093210 — AQUALASE CAPSULE WASH TIP2010-03-04

Injury

218

Malfunction

1,989

Other

1

Total

2,208

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0835-2025 — Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery cartridge Lens Guide, Intraocular Component: N/AClass II·Ongoing·Alcon Research LLC·20241113

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063155.