• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
Malposition of device 154
Device clogged 115
No Known Device Problem 107
Failure to deliver 59
No flow 46
No code available 34
No Information 20
Dislodged or dislocated 20
Occlusion within device 20
Blockage within device or device component 16
Inaccurate delivery 16
Mechanical jam 14
Obstruction within device 12
Device operates differently than expected 11
Defective item 7
Inadequate filtration process 7
Filtration issue 6
Failure to deploy 5
Difficult to deploy 4
Bent 3
Excess flow or overinfusion 3
Use of Device Issue 3
Failure to separate 3
Detachment of device or device component 2
Device disinfection or sterilization issue 2
Unstable 2
Component missing 2
Difficult to position 2
Extrusion 2
Foreign material present in device 1
Improper device output 1
Material integrity issue 1
Packaging issue 1
Positioning Issue 1
Therapeutic or diagnostic output failure 1
Unintended movement 1
Failure to prime 1
Sticking 1
Instruction for use issue 1
Leak 1
Loose or intermittent connection 1
Material erosion 1
Hole in material 1
Break 1
Corrosion 1
Incomplete or missing packaging 1
Valve(s), failure of 1
Device damaged prior to use 1
Defective component 1
Delivery system failure 1
Physical resistance 1
Device Issue 1
Total Device Problems 720

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

-
-