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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 70 70

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 917 1283
Complete Blockage 211 211
Physical Resistance/Sticking 207 207
Migration 113 113
Device Appears to Trigger Rejection 91 91
Malposition of Device 72 194
Mechanical Jam 71 71
Fracture 66 66
Appropriate Term/Code Not Available 60 60
Material Twisted/Bent 50 50
Obstruction of Flow 42 42
Device Dislodged or Dislocated 35 35
Off-Label Use 28 28
Retraction Problem 27 27
Break 21 21
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
Defective Device 8 8
Positioning Failure 8 8
Material Erosion 8 8
Infusion or Flow Problem 7 7
Material Deformation 5 5
No Flow 5 5
Patient-Device Incompatibility 5 5
Material Too Rigid or Stiff 5 5
Delivered as Unsterile Product 4 4
Use of Device Problem 4 4
Difficult to Remove 4 4
Failure to Advance 4 4
Separation Failure 4 4
Unintended Movement 4 4
Positioning Problem 4 4
Activation Problem 4 4
Device Fell 3 3
Therapeutic or Diagnostic Output Failure 3 3
No Apparent Adverse Event 3 3
Filtration Problem 3 3
Mechanical Problem 3 3
Migration or Expulsion of Device 3 3
Material Fragmentation 2 2
Material Disintegration 2 2
Output Problem 2 2
Priming Problem 1 1
Difficult or Delayed Separation 1 1
Missing Information 1 1
Firing Problem 1 1
Material Split, Cut or Torn 1 1
Ejection Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Material Protrusion/Extrusion 1 1
Optical Obstruction 1 1
Output below Specifications 1 1
Detachment of Device or Device Component 1 1
Difficult to Advance 1 1
Entrapment of Device 1 1
Failure to Discharge 1 1
Material Discolored 1 1
Device Alarm System 1 1
Contamination 1 1
Difficult or Delayed Positioning 1 1
Excess Flow or Over-Infusion 1 1
Difficult to Insert 1 1
Leak/Splash 1 1
Unintended Ejection 1 1
Inaccurate Delivery 1 1
Insufficient Flow or Under Infusion 1 1
Failure to Prime 1 1
Product Quality Problem 1 1
Failure to Read Input Signal 1 1
Inadequacy of Device Shape and/or Size 1 1
Unstable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Intraocular Pressure Increased 482 604
Eye Injury 332 332
No Clinical Signs, Symptoms or Conditions 279 279
Erosion 186 186
Endophthalmitis 167 167
Intraocular Pressure Decreased 167 167
Loss of Vision 131 131
No Consequences Or Impact To Patient 118 118
Intraocular Pressure, Delayed, Uncontrolled 106 106
Visual Impairment 105 105
Hyphema 104 226
Fibrosis 90 90
Hemorrhage/Bleeding 75 75
No Code Available 73 73
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 71 71
Corneal Edema 62 62
Insufficient Information 58 58
Macular Edema 52 52
Retinal Detachment 51 51
Glaucoma 50 50
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 33 33
Therapeutic Response, Decreased 33 33
Fluid Discharge 33 33
Intraocular Infection 32 32
Pain 31 31
Vitreous Hemorrhage 29 29
Keratitis 26 26
Blurred Vision 20 20
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 Clouding/Hazing 9 9
Hypopyon 8 8
Corneal Ulcer 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 Tissue Injury 4 4
Obstruction/Occlusion 3 3
Microcysts, Epithelial 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
Unspecified Eye / Vision Problem 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
Excessive Tear Production 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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