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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)
2020 2021 2022 2023 2024 2025
6 6 5 6 4 4

MDR Year MDR Reports MDR Events
2020 197 807
2021 243 6709
2022 239 11951
2023 185 185
2024 163 163
2025 65 65

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 440 7638
Malposition of Device 219 2781
Break 121 5245
Obstruction of Flow 94 2046
Insufficient Information 59 59
Device Dislodged or Dislocated 46 1266
Use of Device Problem 22 266
Migration 22 22
Contamination 19 629
Defective Device 7 7
Separation Failure 7 7
Positioning Problem 7 7
Migration or Expulsion of Device 7 7
Patient-Device Incompatibility 6 6
Difficult to Advance 5 5
Device Stenosis 5 5
Failure to Eject 4 4
Separation Problem 4 4
Nonstandard Device 4 4
Failure to Advance 4 4
Material Twisted/Bent 4 4
Fracture 4 126
Improper or Incorrect Procedure or Method 4 4
Appropriate Term/Code Not Available 3 3
No Apparent Adverse Event 3 3
Difficult to Insert 3 3
Complete Blockage 3 3
Lack of Effect 2 2
Biocompatibility 2 2
Contamination /Decontamination Problem 2 124
Activation, Positioning or Separation Problem 2 2
Patient Device Interaction Problem 1 1
Firing Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Excess Flow or Over-Infusion 1 1
Power Problem 1 1
Unsealed Device Packaging 1 123
Particulates 1 1
Device Appears to Trigger Rejection 1 1
Retraction Problem 1 1
Mechanical Jam 1 1
Difficult or Delayed Activation 1 1
Material Deformation 1 1
Detachment of Device or Device Component 1 1
Difficult to Open or Close 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Intraocular Pressure Increased 279 5159
No Clinical Signs, Symptoms or Conditions 185 6651
Hyphema 158 3940
Foreign Body In Patient 113 2919
Eye Injury 89 211
Inflammation 86 1184
Visual Impairment 84 1914
Corneal Edema 60 914
Insufficient Information 59 303
Iritis 58 1034
Blurred Vision 53 175
Macular Edema 50 416
Adhesion(s) 46 656
Eye Pain 44 44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 39 161
No Consequences Or Impact To Patient 37 1013
Uveitis 37 647
Intraocular Pressure Decreased 30 152
Loss of Vision 22 388
Endophthalmitis 19 873
Visual Disturbances 17 17
Pain 17 749
Corneal Decompensation 15 15
No Known Impact Or Consequence To Patient 14 136
No Code Available 13 13
Headache 10 10
Vitreous Hemorrhage 9 9
Dry Eye(s) 8 8
Foreign Body Sensation in Eye 7 7
Hypersensitivity/Allergic reaction 7 7
UGH (Uveitis Glaucoma Hyphema) Syndrome 7 7
Capsular Bag Tear 7 129
Scar Tissue 6 6
Red Eye(s) 6 128
Hemorrhage/Bleeding 6 6
Corneal Clouding/Hazing 6 6
Glaucoma 6 6
Failure of Implant 5 5
Itching Sensation 5 5
Excessive Tear Production 5 5
Hypopyon 5 127
Discomfort 5 5
Eye Infections 5 127
Fluid Discharge 5 5
Swelling/ Edema 4 4
Keratitis 4 126
Therapeutic Response, Decreased 4 4
Corneal Abrasion 4 4
Device Embedded In Tissue or Plaque 4 4
Intraocular Pressure, Delayed, Uncontrolled 3 3

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