Recall Z-0978-2017— Alcon Research, Ltd.

Name: FDA recall Z-0978-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-05

Class II · Terminated

Class II FDA medical device recall by Alcon Research, Ltd., initiated 2016-09-05, terminated 2017-02-10. It names one FDA 510(k) clearance: K112977. Product: Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal. Reason: The intraocular lens could become lodged within the cartridge.

Recalling firm: Alcon Research, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2016-09-05
Terminated: 2017-02-10
Firm location: Fort Worth, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K112977 — MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)Alcon Research, Ltd.·cleared 2012-03-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal

Reason for recall

The intraocular lens could become lodged within the cartridge

Data sourced from openFDA. This site is unofficial and independent of the FDA.