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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
Device clogged 115
No Known Device Problem 113
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
Mechanical jam 14
Device operates differently than expected 13
Obstruction within device 13
Inadequate filtration process 7
Defective item 7
Filtration issue 6
Failure to deploy 5
Difficult to deploy 4
Bent 3
Use of Device Issue 3
Failure to separate 3
Excess flow or overinfusion 3
Difficult to position 2
Break 2
Unstable 2
Component missing 2
Detachment of device or device component 2
Device disinfection or sterilization issue 2
Extrusion 2
Unintended movement 2
Packaging issue 1
Positioning Issue 1
Therapeutic or diagnostic output failure 1
Foreign material present in device 1
Improper device output 1
Material integrity issue 1
Valve(s), failure of 1
Device damaged prior to use 1
Defective component 1
Physical resistance 1
Delivery system failure 1
Incomplete or missing packaging 1
Device Issue 1
Corrosion 1
Material erosion 1
Fluid leak 1
Hole in material 1
Failure to prime 1
Sticking 1
Instruction for use issue 1
Leak 1
Loose or intermittent connection 1
Total Device Problems 738

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 Innovative Ophthalmic Products, Inc II Mar-25-2016

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