FDA Device recall Z-2834-2016
LAUREATE World Phaco System
- FDA Device
- Class II
- terminated
- Published 2016-09-21
On 2016-09-21 the FDA classified a Class II recall of LAUREATE World Phaco System by Alcon Research, citing steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2834-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-28 |
| Published | 2016-09-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Alcon Research |
| Distribution | n/a |
Product
LAUREATE World Phaco System
Reason
Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)
Identifiers
| code_info | Lot Numbers: 1658863H, 1805033H, 1805034H, 1817516H, 1817517H, 1826141H, 1826142H, 1857622H, 1857623H, 1868399H, 1868400H |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2834-2016%22
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