Recall Z-1940-2016 ยท HQC Unit, Phacofragmentation
Alcon Research, Ltd.
CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
| Date | Jun 9, 2016 (initiated Apr 28, 2016) |
| Status | Terminated |
| Reason | Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due to the possible presence of a molding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line. |
| Root cause | Process control |
| Action | The affected consignees were sent a recall notification letter on 4/28/16. |
| Quantity | 156,712 units |
| Distribution | US, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colunbia, Croatia, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Phili |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121555 | CENTURION VISION SYSTEM Alcon Laboratories, Inc., Dec 21, 2012 |