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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
Product CodeKYF
Regulation Number 886.3920
Device Class 2


Premarket Reviews
ManufacturerDecision
GLAUKOS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NEW WORLD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 516 516
2020 437 437
2021 412 412
2022 299 787
2023 314 314
2024 89 89

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 924 1290
Physical Resistance/Sticking 212 212
Complete Blockage 212 212
Migration 116 116
Device Appears to Trigger Rejection 92 92
Malposition of Device 72 194
Mechanical Jam 71 71
Fracture 67 67
Appropriate Term/Code Not Available 60 60
Material Twisted/Bent 50 50
Obstruction of Flow 44 44
Device Dislodged or Dislocated 36 158
Off-Label Use 28 28
Retraction Problem 27 27
Break 22 22
Improper or Incorrect Procedure or Method 20 20
Failure to Eject 17 17
Defective Component 13 13
Failure to Deliver 11 11
Partial Blockage 11 11
Insufficient Information 10 10
Dull, Blunt 10 10
Activation, Positioning or Separation Problem 10 10
Material Erosion 8 8
Defective Device 8 8
Positioning Failure 8 8
Infusion or Flow Problem 7 7
Patient-Device Incompatibility 5 5
No Flow 5 5
Material Too Rigid or Stiff 5 5
Material Deformation 5 5
Unintended Movement 4 4
Separation Failure 4 4
Positioning Problem 4 4
Use of Device Problem 4 4
Activation Problem 4 4
Delivered as Unsterile Product 4 4
Difficult to Remove 4 4
Failure to Advance 4 4
Device Fell 3 3
Migration or Expulsion of Device 3 3
Therapeutic or Diagnostic Output Failure 3 3
No Apparent Adverse Event 3 3
Filtration Problem 3 3
Mechanical Problem 3 3
Output Problem 2 2
Material Fragmentation 2 2
Material Disintegration 2 2
Failure to Prime 1 1
Product Quality Problem 1 1
Material Discolored 1 1
Unstable 1 1
Failure to Read Input Signal 1 1
Contamination 1 1
Missing Information 1 1
Material Split, Cut or Torn 1 1
Unintended Ejection 1 1
Difficult or Delayed Separation 1 1
Priming Problem 1 1
Difficult or Delayed Positioning 1 1
Output below Specifications 1 1
Optical Obstruction 1 1
Material Protrusion/Extrusion 1 1
Excess Flow or Over-Infusion 1 1
Inadequacy of Device Shape and/or Size 1 1
Leak/Splash 1 1
Device Contamination with Chemical or Other Material 1 1
Ejection Problem 1 1
Detachment of Device or Device Component 1 1
Inaccurate Delivery 1 1
Failure to Discharge 1 1
Firing Problem 1 1
Difficult to Advance 1 1
Insufficient Flow or Under Infusion 1 1
Entrapment of Device 1 1
Difficult to Insert 1 1
Device Alarm System 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Intraocular Pressure Increased 488 732
Eye Injury 334 334
No Clinical Signs, Symptoms or Conditions 287 287
Erosion 187 187
Intraocular Pressure Decreased 169 169
Endophthalmitis 168 168
Loss of Vision 132 254
No Consequences Or Impact To Patient 118 118
Intraocular Pressure, Delayed, Uncontrolled 106 106
Visual Impairment 106 106
Hyphema 106 228
Fibrosis 90 90
Hemorrhage/Bleeding 75 75
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 74 74
No Code Available 73 73
Corneal Edema 62 62
Insufficient Information 59 59
Macular Edema 52 52
Glaucoma 52 52
Retinal Detachment 51 51
Failure of Implant 45 45
Uveitis 41 163
Inflammation 40 162
No Known Impact Or Consequence To Patient 40 40
Corneal Stromal Edema 35 35
Corneal Decompensation 34 34
Therapeutic Response, Decreased 33 33
Fluid Discharge 33 33
Intraocular Infection 32 32
Pain 32 32
Vitreous Hemorrhage 29 29
Keratitis 26 26
Blurred Vision 22 22
Corneal Touch 19 19
Wound Dehiscence 19 19
No Patient Involvement 17 17
Cataract 16 138
Iritis 16 138
Eye Infections 14 14
No Information 12 12
Hyperemia 12 12
Vitrectomy 11 11
Corneal Abrasion 10 10
Corneal Ulcer 9 9
Corneal Clouding/Hazing 9 9
Hypopyon 8 8
Eye Pain 8 8
Collapse 7 7
Adhesion(s) 7 129
Perforation 7 7
Foreign Body In Patient 6 128
Vitreous Detachment 5 5
Scarring 5 5
Foreign Body Sensation in Eye 5 5
Dry Eye(s) 4 4
Red Eye(s) 4 4
Visual Disturbances 4 4
Discomfort 4 4
Ptosis 4 4
Unspecified Eye / Vision Problem 4 4
Unspecified Tissue Injury 4 4
Obstruction/Occlusion 3 3
Microcysts, Epithelial 3 3
Excessive Tear Production 3 3
Therapeutic Effects, Unexpected 3 3
Edema 3 3
Ecchymosis 2 2
Conjunctivitis 2 2
Cyst(s) 2 2
Vitreous Floaters 2 2
Headache 2 2
Hematoma 2 2
Unspecified Infection 2 2
Vitreous Loss 2 2
Capsular Bag Tear 2 124
Reaction 2 2
Patient Problem/Medical Problem 2 2
Not Applicable 2 2
Embolism/Embolus 2 2
Toxic Anterior Segment Syndrome (TASS) 1 1
Device Embedded In Tissue or Plaque 1 1
Eye Burn 1 1
Vomiting 1 1
Seizures, Grand-Mal 1 1
Clouding, Central Corneal 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Disability 1 1
Tissue Damage 1 1
UGH (Uveitis-Glaucoma-Hyphema) Syndrome 1 1
Swelling 1 1
Retinal Degeneration 1 1
Retinal Tear 1 1
Irritation 1 1
Necrosis 1 1
Nerve Damage 1 1
Neuropathy 1 1
Low Blood Pressure/ Hypotension 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Allergan PLC II Dec-04-2019
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