Device product
LAUREATE World Phaco System
Z-2834-2016
Product summary
- 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
Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)