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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 55 55

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 561 7759
Malposition of Device 226 2788
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 318 5199
Hyphema 180 3962
No Clinical Signs, Symptoms or Conditions 153 6619
Foreign Body In Patient 130 2936
Visual Impairment 107 1937
Inflammation 101 1199
No Code Available 84 84
Eye Injury 83 205
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 47 413
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 20 142
Endophthalmitis 18 872
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 8 130
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
Excessive Tear Production 4 4
Device Embedded In Tissue or Plaque 4 4
Fibrosis 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
Irritability 2 2
No Patient Involvement 2 2
Eye Infections 2 124
Not Applicable 1 1
Nervous System Injury 1 1
Zonular Dehiscence 1 1
Vitrectomy 1 1
Vitreous Detachment 1 1
Prolapse 1 1
Implant Pain 1 1
Unspecified Eye / Vision Problem 1 1
Toxic Anterior Segment Syndrome (TASS) 1 123
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
Fall 1 1

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