Recall Z-2834-2016 ยท HQC Unit, Phacofragmentation
Alcon Research, Ltd.
LAUREATE World Phaco System
| Date | Sep 15, 2016 (initiated Jul 28, 2016) |
| Status | Terminated |
| Reason | Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU) |
| Root cause | Labeling Change Control |
| Action | All remaining inventory of the identified affected products within Alcon DCs will be supplied corrected directions for use material prior to any further shipments. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021566 | INFINITI Alcon Laboratories, Inc., Jul 2, 2002 |