Recall Z-2834-2016— Alcon Research, Ltd.

Name: FDA recall Z-2834-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-28

Class II · Terminated

Class II FDA medical device recall by Alcon Research, Ltd., initiated 2016-07-28, terminated 2017-06-07. It names one FDA 510(k) clearance: K021566. Product: LAUREATE World Phaco System. Reason: Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU).

Recalling firm: Alcon Research, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2016-07-28
Terminated: 2017-06-07
Firm location: Fort Worth, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K021566 — INFINITIAlcon Laboratories, Inc.·cleared 2002-07-02

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

LAUREATE World Phaco System

Reason for recall

Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)

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