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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)
2018 2019 2020 2021 2022 2023 2024
9 6 6 6 5 6 2

MDR Year MDR Reports MDR Events
2018 511 511
2019 352 474
2020 197 807
2021 243 6709
2022 239 11951
2023 185 185
2024 81 81

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 804 8002
Malposition of Device 276 2838
Insufficient Information 137 137
Obstruction of Flow 134 2086
Break 105 5229
Device Dislodged or Dislocated 57 1277
Patient-Device Incompatibility 38 38
Appropriate Term/Code Not Available 30 30
Use of Device Problem 27 271
Migration or Expulsion of Device 25 25
Positioning Problem 21 21
Contamination 18 628
Improper or Incorrect Procedure or Method 16 16
Migration 14 14
Device Operates Differently Than Expected 11 11
Activation, Positioning or Separation Problem 9 9
No Apparent Adverse Event 9 9
Therapeutic or Diagnostic Output Failure 8 8
Defective Device 8 8
Unexpected Therapeutic Results 8 8
Nonstandard Device 8 8
Separation Failure 7 7
Complete Blockage 6 6
Difficult to Advance 6 6
Material Protrusion/Extrusion 6 6
Material Twisted/Bent 5 5
Failure to Advance 5 5
Difficult to Insert 5 5
Patient Device Interaction Problem 5 127
Separation Problem 4 4
Failure to Fire 4 4
Contamination /Decontamination Problem 3 125
Extrusion 3 3
Unintended Movement 3 3
Material Integrity Problem 3 3
Failure to Eject 3 3
Fracture 3 125
Unsealed Device Packaging 3 125
Positioning Failure 3 3
Difficult or Delayed Activation 3 3
Increase in Pressure 3 3
Device Appears to Trigger Rejection 3 3
Device Stenosis 3 3
Lack of Effect 2 2
Physical Resistance/Sticking 2 2
Bent 2 2
Entrapment of Device 2 2
Difficult or Delayed Positioning 2 2
Mechanical Problem 2 2
Device Handling Problem 2 2
Mechanical Jam 2 2
Optical Obstruction 2 2
Difficult to Open or Close 2 2
Biocompatibility 2 2
Detachment of Device or Device Component 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Contamination with Chemical or Other Material 1 1
Human-Device Interface Problem 1 1
Material Deformation 1 1
Output Problem 1 1
Power Problem 1 1
Mechanics Altered 1 1
No Flow 1 1
Firing Problem 1 1
Excess Flow or Over-Infusion 1 1
Premature Activation 1 1
Occlusion Within Device 1 1
Fluid/Blood Leak 1 1
Failure to Discharge 1 1
Off-Label Use 1 1
Retraction Problem 1 1
Failure to Read Input Signal 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Slipped 1 1
Physical Resistance 1 1
Structural Problem 1 1
Fitting Problem 1 1
Failure to Deliver 1 1
Dull, Blunt 1 1
Intermittent Loss of Power 1 1
Activation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Intraocular Pressure Increased 465 5346
Hyphema 225 4007
No Code Available 155 155
No Clinical Signs, Symptoms or Conditions 155 6621
Foreign Body In Patient 151 2957
Visual Impairment 145 1975
Inflammation 124 1222
Eye Injury 120 242
No Known Impact Or Consequence To Patient 108 230
Iritis 92 1068
No Consequences Or Impact To Patient 70 1168
Blurred Vision 70 192
Corneal Edema 69 923
Pain 63 796
Loss of Vision 59 425
Macular Edema 52 418
Insufficient Information 45 289
Intraocular Pressure, Delayed, Uncontrolled 42 43
Uveitis 41 651
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 162
Eye Pain 39 39
Adhesion(s) 39 649
Corneal Decompensation 32 32
Hemorrhage/Bleeding 32 32
Intraocular Pressure Decreased 25 147
No Information 24 24
Endophthalmitis 24 878
Visual Disturbances 23 23
Failure of Implant 18 18
Headache 18 18
Vitreous Hemorrhage 15 15
Patient Problem/Medical Problem 14 14
Discomfort 12 12
Tissue Damage 11 11
Foreign Body Sensation in Eye 11 11
Corneal Abrasion 11 11
Dry Eye(s) 10 10
Corneal Clouding/Hazing 10 10
Hypopyon 9 131
Red Eye(s) 9 132
Capsular Bag Tear 9 131
Therapeutic Response, Decreased 8 8
Scar Tissue 8 8
Glaucoma 7 7
Fibrosis 7 7
Fluid Discharge 6 6
Therapeutic Effects, Unexpected 6 6
Hypersensitivity/Allergic reaction 5 5
No Patient Involvement 5 5
Device Embedded In Tissue or Plaque 5 5
Obstruction/Occlusion 4 4
Complaint, Ill-Defined 4 4
Excessive Tear Production 4 4
Injury 4 4
Corneal Touch 4 4
Vitritis 4 126
Retinal Detachment 3 3
Unspecified Infection 3 3
Itching Sensation 3 3
Keratitis 3 125
Nausea 3 3
Emotional Changes 3 3
Microcystic Edema 3 3
Conjunctivitis 3 247
Bacterial Infection 3 3
Low Blood Pressure/ Hypotension 3 3
Reaction 3 3
Vitrectomy 3 3
UGH (Uveitis Glaucoma Hyphema) Syndrome 3 3
Swelling/ Edema 3 3
Increased Sensitivity 2 2
Eye Infections 2 124
Irritability 2 2
Flashers 2 2
Vitreous Floaters 2 2
Erosion 2 2
Cataract 2 2
Wound Dehiscence 2 2
Host-Tissue Reaction 2 2
Corneal Stromal Edema 2 2
Corneal Ulcer 2 2
Edema 2 2
Local Reaction 2 2
Vomiting 2 2
Burning Sensation 2 2
Thrombus 2 2
Retinal Tear 2 2
Swelling 2 2
Vitreous Loss 2 2
Dizziness 1 1
Halo 1 1
Corneal Infiltrates 1 1
Perforation 1 1
Retinal Injury 1 1
Scarring 1 1
Increased Sensitivity 1 1
Irritation 1 1
Intraocular Infection 1 1
Abrasion 1 1
Erythema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research, LTD. I Oct-23-2018
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