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Recall Observatory FDA recall evidence

Device product

LAUREATE World Phaco System

Z-2834-2016

July 28, 2016

Class II

Product summary

Firm
Alcon Research, Ltd.
Event
Event 74825
Status
Terminated
Classification
Class II
Quantity
8,646 UNITS
Official record key
device-enforcement:Z-2834-2016

Official wording

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

Code information: Lot Numbers: 1658863H, 1805033H, 1805034H, 1817516H, 1817517H, 1826141H, 1826142H, 1857622H, 1857623H, 1868399H, 1868400H

Distribution pattern: Burundi, China, Iran, South Korea, Taiwan, Thailand, USA. *** The recalled product is not sold in the USA or its territories. However, donated units are in use by a reduced number of USA clients for Medical Missions outside the country.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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