LAUREATE World Phaco System recall
LAUREATE World Phaco System
Why was LAUREATE World Phaco System recalled?
Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 1658863H, 1805033H, 1805034H, 1817516H, 1817517H, 1826141H, 1826142H, 1857622H, 1857623H, 1868399H, 1868400H
- Product
- LAUREATE World Phaco System
- Recalling firm
- Alcon Research, Ltd.
- 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.
- Recall date
- September 21, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)