LAUREATE World Phaco System
FDA device recall Z-2834-2016 · posted 2016-09-15 · Terminated
Recall details
- Recalling firm
- Alcon Research, Ltd.
- Reason for recall
- Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- HQC
- Quantity affected
- 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 M
- Date initiated
- 2016-07-28
- Date posted
- 2016-09-15
- Date terminated
- 2017-06-07
- Location
- Fort Worth, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFINITI (K021566) | Alcon Laboratories, Inc. | 2002-07-02 |