FDA-Device2016-09-21Class II
LAUREATE World Phaco System
Alcon Research, Ltd.
Hazard
Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)
Sold states
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.
Affected count
8,646 UNITS
Manufactured in
6201 South Fwy, N/A, Fort Worth, TX, United States
Products
LAUREATE World Phaco System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2834-2016Don't want to check this manually?
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