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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intraocular pressure lowering implant
Definition An intraocular pressure lowering implant is a device intended to reduce intraocular pressure when implanted in eyes which have not failed conventional medical and surgical treatment.
Product CodeOGO
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
6 6 6 5 6 2

MDR Year MDR Reports MDR Events
2019 352 474
2020 197 807
2021 243 6709
2022 239 11951
2023 185 185
2024 66 66

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 570 7768
Malposition of Device 229 2791
Obstruction of Flow 106 2058
Break 103 5227
Insufficient Information 67 67
Device Dislodged or Dislocated 49 1269
Use of Device Problem 23 267
Patient-Device Incompatibility 21 21
Contamination 17 627
Migration 14 14
Appropriate Term/Code Not Available 12 12
Positioning Problem 11 11
Therapeutic or Diagnostic Output Failure 8 8
Migration or Expulsion of Device 8 8
Improper or Incorrect Procedure or Method 7 7
Unexpected Therapeutic Results 6 6
Nonstandard Device 6 6
Defective Device 6 6
No Apparent Adverse Event 6 6
Patient Device Interaction Problem 5 127
Activation, Positioning or Separation Problem 5 5
Separation Failure 5 5
Difficult to Advance 4 4
Complete Blockage 4 4
Difficult to Insert 4 4
Separation Problem 4 4
Failure to Advance 4 4
Device Stenosis 3 3
Material Twisted/Bent 3 3
Device Appears to Trigger Rejection 3 3
Fracture 3 125
Failure to Fire 3 3
Difficult or Delayed Activation 2 2
Biocompatibility 2 2
Contamination /Decontamination Problem 2 124
Increase in Pressure 2 2
Material Integrity Problem 2 2
Material Protrusion/Extrusion 2 2
Failure to Eject 2 2
Lack of Effect 2 2
Firing Problem 1 1
Intermittent Loss of Power 1 1
Activation Problem 1 1
Mechanical Jam 1 1
Power Problem 1 1
Output Problem 1 1
Off-Label Use 1 1
Retraction Problem 1 1
Failure to Read Input Signal 1 1
Excess Flow or Over-Infusion 1 1
Unsealed Device Packaging 1 123
Positioning Failure 1 1
Entrapment of Device 1 1
Structural Problem 1 1
Detachment of Device or Device Component 1 1
Difficult to Open or Close 1 1
Human-Device Interface Problem 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Intraocular Pressure Increased 319 5200
Hyphema 182 3964
No Clinical Signs, Symptoms or Conditions 153 6619
Foreign Body In Patient 131 2937
Visual Impairment 107 1937
Inflammation 102 1200
Eye Injury 84 206
No Code Available 84 84
Iritis 70 1046
Corneal Edema 55 909
No Consequences Or Impact To Patient 52 1150
No Known Impact Or Consequence To Patient 50 172
Macular Edema 49 415
Blurred Vision 45 167
Insufficient Information 42 286
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 162
Eye Pain 39 39
Adhesion(s) 38 648
Loss of Vision 34 400
Pain 34 767
Uveitis 33 643
Corneal Decompensation 29 29
Intraocular Pressure Decreased 23 145
Endophthalmitis 19 873
Visual Disturbances 17 17
Headache 15 15
Failure of Implant 13 13
Intraocular Pressure, Delayed, Uncontrolled 12 13
Vitreous Hemorrhage 12 12
Tissue Damage 11 11
Dry Eye(s) 10 10
Foreign Body Sensation in Eye 9 9
Patient Problem/Medical Problem 9 9
Capsular Bag Tear 9 131
Hemorrhage/Bleeding 8 8
Corneal Clouding/Hazing 8 8
Scar Tissue 8 8
Red Eye(s) 8 131
Therapeutic Response, Decreased 8 8
Discomfort 7 7
Corneal Abrasion 7 7
Glaucoma 6 6
Fluid Discharge 6 6
No Information 6 6
Hypopyon 5 127
Hypersensitivity/Allergic reaction 4 4
Therapeutic Effects, Unexpected 4 4
Device Embedded In Tissue or Plaque 4 4
Fibrosis 4 4
Excessive Tear Production 4 4
Obstruction/Occlusion 3 3
Swelling/ Edema 3 3
UGH (Uveitis Glaucoma Hyphema) Syndrome 3 3
Itching Sensation 3 3
Keratitis 3 125
Injury 3 3
Vitritis 3 125
Conjunctivitis 3 247
Corneal Touch 3 3
Microcystic Edema 3 3
Corneal Stromal Edema 2 2
Emotional Changes 2 2
Corneal Ulcer 2 2
Erosion 2 2
Cataract 2 2
Wound Dehiscence 2 2
Flashers 2 2
Vitreous Floaters 2 2
Vitreous Loss 2 2
Nausea 2 2
Retinal Detachment 2 2
Swelling 2 2
Retinal Tear 2 2
Increased Sensitivity 2 2
Eye Infections 2 124
Irritability 2 2
No Patient Involvement 2 2
Nervous System Injury 1 1
Not Applicable 1 1
Zonular Dehiscence 1 1
Vitrectomy 1 1
Vitreous Detachment 1 1
Needle Stick/Puncture 1 1
Prolapse 1 1
Toxic Anterior Segment Syndrome (TASS) 1 123
Implant Pain 1 1
Unspecified Eye / Vision Problem 1 1
Scarring 1 1
Thrombus 1 1
Retinal Injury 1 1
Perforation 1 1
Local Reaction 1 1
Irritation 1 1
Vomiting 1 1
Dizziness 1 1
Halo 1 1
Corneal Infiltrates 1 1
Deformity/ Disfigurement 1 1
Inadequate Pain Relief 1 1
Numbness 1 1

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