Recall Z-2834-2016
Alcon Research, Ltd. · initiated July 28, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
LAUREATE World Phaco System
Codes / lots: Lot Numbers: 1658863H, 1805033H, 1805034H, 1817516H, 1817517H, 1826141H, 1826142H, 1857622H, 1857623H, 1868399H, 1868400H
Reason for recall
Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)
FDA-determined cause: Labeling Change Control
Action taken
All remaining inventory of the identified affected products within Alcon DCs will be supplied corrected directions for use material prior to any further shipments.
Details
- Recall number
- Z-2834-2016
- Initiated
- July 28, 2016
- Posted by FDA
- September 15, 2016
- Terminated
- June 7, 2017
- Product code
- HQC – Unit, Phacofragmentation
- Quantity
- 8,646 UNITS
- Distribution
- 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.
- Recalling firm
- Alcon Research, Ltd., Fort Worth, TX