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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implant, corneal, refractive
Product CodeLQE
Device Class Humanitarian Device Exemption

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
1 0 0 0 0 1 1 0 1 1

Device Problems
No Known Device Problem 13
Not Applicable 5
Improper or incorrect procedure or method 3
Wrinkled 1
No Information 1
Total Device Problems 23

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AcuFocus, Inc. II Mar-24-2016

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