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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
GLAUKOS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NEW WORLD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 412 412
2022 299 787
2023 314 314
2024 334 364
2025 281 281
2026 135 145

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 768 1149
Physical Resistance/Sticking 301 301
Complete Blockage 185 190
Device Appears to Trigger Rejection 110 110
Migration 81 81
Mechanical Jam 63 63
Break 46 54
Device Dislodged or Dislocated 40 165
Appropriate Device Problem Term/Code Not Available 37 48
Malposition of Device 33 155
Failure to Eject 25 25
Fracture 24 24
Material Twisted/Bent 22 22
Defective Device 19 19
Obstruction of Flow 16 16
Retraction Problem 13 13
Dull, Blunt 13 13
Failure to Deliver 8 8
No Apparent Adverse Event 6 6
Infusion or Flow Problem 6 6
Off-Label Use 5 5
Delivered as Unsterile Product 5 5
Migration or Expulsion of Device 5 5
Leak/Splash 5 5
Failure to Advance 4 4
Detachment of Device or Device Component 4 4
Difficult to Insert 3 3
Contamination 3 3
Device Difficult to Setup or Prepare 3 11
Use of Device Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Suction Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Patient-Device Incompatibility 2 2
Material Deformation 2 2
Partial Blockage 2 2
Device Contamination with Chemical or Other Material 2 2
Inaccurate Delivery 1 1
Missing Information 1 1
Failure to Prime 1 1
No Flow 1 1
Failure to Discharge 1 1
Difficult or Delayed Separation 1 1
Difficult or Delayed Positioning 1 1
Insufficient Flow or Under Infusion 1 1
Insufficient Device Problem Information 1 1
Component Missing 1 1
Unintended Ejection 1 1
Positioning Failure 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 527 536
Intraocular Pressure Increased 396 649
Intraocular Pressure Decreased 241 253
Eye Injury 202 336
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 118 122
Visual Impairment 108 116
Erosion 105 105
Endophthalmitis 104 107
Loss of Vision 94 218
Hyphema 80 207
Insufficient Information 79 79
Failure of Implant 64 64
Glaucoma 51 52
Corneal Stromal Edema 39 44
Macular Edema 39 39
Hemorrhage/Blood Loss/Bleeding 35 35
Retinal Detachment 32 35
Vitreous Hemorrhage 32 34
Inflammation 32 155
Corneal Decompensation 29 34
Corneal Edema 28 28
Uveitis 28 150
Intraocular Infection 26 26
Cataract 24 146
Choroidal Hemorrhage 23 26
Fibrosis 23 23
Wound Dehiscence 23 25
Keratitis 22 22
Eye Infections 20 21
Foreign Body In Patient 20 142
Fluid Discharge 18 18
Adhesion(s) 16 138
Eye Pain 16 16
Corneal Endothelial Cell Loss 16 138
Iritis 13 135
Corneal Abrasion 12 12
Blurred Vision 12 13
Visual Disturbances 12 12
Pain 11 11
Foreign Body Sensation in Eye 11 11
Corneal Clouding/Hazing 10 10
Perforation 9 9
Corneal Ulcer 7 7
Unspecified Eye / Vision Problem 6 11
Corneal Touch 5 5
Eye Irritation 5 5
Hyperemia 5 5
Discomfort 5 5
Choroidal effusion 5 8
Unspecified Tissue Injury 4 4

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