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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device intraocular pressure lowering implant
Definition An intraocular pressure lowering implant is a device intended to reduce intraocular pressure when implanted in eyes which have not failed conventional medical and surgical treatment.
Product CodeOGO
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
0 1 1 1 0 4 7 2 3 6 0

Device Problems
No Known Device Problem 63
Malposition of device 38
Use of Device Issue 20
Dislodged or dislocated 9
Occlusion within device 7
No Information 7
Difficult to position 7
Blockage within device or device component 4
Unsealed device packaging 3
Obstruction within device 3
Improper or incorrect procedure or method 3
Unexpected therapeutic results 2
Patient-device incompatibility 2
Unknown (for use when the device problem is not known) 2
Difficult to deploy 2
Migration of device or device component 1
Device operates differently than expected 1
Failure to advance 1
Unintended movement 1
Positioning Issue 1
Component falling 1
Entrapment of device or device component 1
Total Device Problems 179

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