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Alcon Research, Ltd. recalls LAUREATE World Phaco System
Recalled September 21, 2016 · FDA recall Z-2834-2016 · Alcon Research
Hazard
Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU) · FDA Class II
Units
8,646 UNITS
Sold at
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.
Description
Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)
Product
LAUREATE World Phaco System
Manufacturer(s)
Alcon Research, Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →