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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
NEW WORLD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
OPTONOL, LTD
  SUBSTANTIALLY EQUIVALENT 2
STAAR
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to deliver 29
Device clogged 28
No Known Device Problem 20
No code available 15
Occlusion within device 13
No Information 12
Mechanical jam 12
No flow 12
Inaccurate delivery 9
Dislodged or dislocated 6
Obstruction within device 5
Defective item 5
Malposition of device 5
Blockage within device or device component 3
Component missing 2
Difficult to deploy 2
Failure to deploy 2
Extrusion 2
Device disinfection or sterilization issue 2
Device operates differently than expected 1
Packaging issue 1
Positioning Issue 1
Bent 1
Hole in material 1
Excess flow or overinfusion 1
Instruction for use issue 1
Loose or intermittent connection 1
Difficult to position 1
Sticking 1
Unstable 1
Use of Device Issue 1
Device damaged prior to use 1
Inadequate filtration process 1
Incomplete or missing packaging 1
Break 1
Delivery system failure 1
Detachment of device or device component 1
Total Device Problems 202

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0


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