Reported Sep 21, 2016 · Terminated
LAUREATE World Phaco System
Alcon Research, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alcon Research, Ltd. · 6201 South Fwy · Fort Worth, TX · 76134-2099
Is this the product you have?
- LAUREATE World Phaco System
- Lot codes and dates
- Lot Numbers
1658863H1805033H1805034H1817516H1817517H1826141H1826142H1857622H1857623H1868399H1868400H
- Lot Numbers
- Amount recalled
- 8,646 UNITS
Why it was recalled
Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU)
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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