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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implant, eye valve
Regulation Description Aqueous shunt.
Product CodeKYF
Regulation Number 886.3920
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEW WORLD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
OPTONOL, LTD
  SUBSTANTIALLY EQUIVALENT 2
STAAR
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Malposition of device 155
No Known Device Problem 121
Device clogged 117
Failure to deliver 59
No flow 47
No code available 35
No Information 21
Occlusion within device 21
Dislodged or dislocated 20
Blockage within device or device component 17
Inaccurate delivery 16
Obstruction within device 15
Mechanical jam 14
Device operates differently than expected 13
Inadequate filtration process 8
Defective item 7
Break 6
Not Applicable 6
Filtration issue 6
Failure to deploy 5
Component missing 5
Fracture 5
Use of Device Issue 4
Difficult to deploy 4
Bent 3
Difficult to position 3
Excess flow or overinfusion 3
Failure to separate 3
Extrusion 3
Detachment of device or device component 2
Device disinfection or sterilization issue 2
Buckled material 2
Foreign material present in device 2
Unintended movement 2
Device Issue 2
Migration of device or device component 2
Unstable 2
Hole in material 1
Valve(s), failure of 1
Device damaged prior to use 1
Defective component 1
Incomplete or missing packaging 1
Physical resistance 1
Instruction for use issue 1
Leak 1
Loose or intermittent connection 1
Failure to prime 1
Sticking 1
Material erosion 1
Fluid leak 1
Corrosion 1
Improper device output 1
Material integrity issue 1
Packaging issue 1
Positioning Issue 1
Therapeutic or diagnostic output failure 1
Delivery system failure 1
Deployment issue 1
Patient-device incompatibility 1
Total Device Problems 780

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Innovative Ophthalmic Products, Inc II Mar-25-2016

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