FDA Medical Device Recalls (openFDA)
Alcon Research, Ltd.: LAUREATE World Phaco System
- Recall number
- Z-2834-2016
- Recalling firm
- Alcon Research, Ltd.
- Product
- LAUREATE World Phaco System
- Status
- Terminated
- Initiated
- 2016-07-28
- Posted
- 2016-09-15
- Terminated
- 2017-06-07
- 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.
- Lot, serial or model codes
- Lot Numbers: 1658863H, 1805033H, 1805034H, 1817516H, 1817517H, 1826141H, 1826142H, 1857622H, 1857623H, 1868399H, 1868400H
- 510(k) numbers
- ["K021566"]
- PMA numbers
- not on file
- Product code
- HQC
- Firm FEI
- 1610287
- Firm city
- Fort Worth
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28