Alcon Research, Ltd. recalls LAUREATE World Phaco System
- Recall date
- July 28, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2834-2016
- FDA classification
- Class II
- Brand / firm
- Alcon Research, Ltd.
- Sold / distributed
- 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.
Why it was recalled
Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
LAUREATE World Phaco System
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