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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)
2017 2018 2019 2020 2021 2022 2023 2024
5 9 6 6 6 5 6 1

MDR Year MDR Reports MDR Events
2017 298 298
2018 511 511
2019 352 474
2020 197 807
2021 243 6709
2022 239 11951
2023 185 185
2024 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 909 8107
Malposition of Device 300 2862
Insufficient Information 181 181
Obstruction of Flow 150 2102
Break 102 5226
Device Dislodged or Dislocated 65 1285
Patient-Device Incompatibility 46 46
Use of Device Problem 40 284
Appropriate Term/Code Not Available 36 36
Device Operates Differently Than Expected 33 33
Migration or Expulsion of Device 31 31
Improper or Incorrect Procedure or Method 23 23
Positioning Problem 23 23
Contamination 18 628
Migration 14 14
Activation, Positioning or Separation Problem 11 11
No Apparent Adverse Event 9 9
Therapeutic or Diagnostic Output Failure 8 8
Defective Device 8 8
Nonstandard Device 8 8
Unexpected Therapeutic Results 8 8
Difficult to Insert 7 7
Complete Blockage 7 7
Material Protrusion/Extrusion 6 6
Unintended Movement 5 5
Failure to Advance 5 5
Separation Failure 5 5
Difficult to Advance 5 5
Patient Device Interaction Problem 5 127
Separation Problem 4 4
Failure to Fire 4 4
Material Twisted/Bent 4 4
Increase in Pressure 4 4
Device Appears to Trigger Rejection 3 3
Bent 3 3
Difficult or Delayed Positioning 3 3
Positioning Failure 3 3
Fracture 3 125
Unsealed Device Packaging 3 125
Contamination /Decontamination Problem 3 125
Material Integrity Problem 3 3
Optical Obstruction 3 3
Difficult or Delayed Activation 3 3
Physical Resistance 3 3
Extrusion 3 3
Device Stenosis 3 3
Lack of Effect 2 2
Physical Resistance/Sticking 2 2
Failure to Eject 2 2
Difficult to Open or Close 2 2
Biocompatibility 2 2
Device Handling Problem 2 2
Mechanical Jam 2 2
Occlusion Within Device 2 2
Material Fragmentation 2 2
Mechanical Problem 2 2
Entrapment of Device 2 2
Dull, Blunt 2 2
Invalid Sensing 2 2
Component Missing 1 1
Failure to Deliver 1 1
Fitting Problem 1 1
Structural Problem 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
Off-Label Use 1 1
Unable to Obtain Readings 1 1
Device Inoperable 1 1
Filling Problem 1 1
Fluid/Blood Leak 1 1
Detachment Of Device Component 1 1
Failure to Discharge 1 1
Excess Flow or Over-Infusion 1 1
Premature Activation 1 1
Mechanics Altered 1 1
No Flow 1 1
Detachment of Device or Device Component 1 1
Output Problem 1 1
Power Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Contamination with Chemical or Other Material 1 1
Human Factors Issue 1 1
Human-Device Interface Problem 1 1
Material Deformation 1 1
Firing Problem 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 533 5414
Hyphema 252 4034
No Code Available 197 197
Visual Impairment 169 1999
Foreign Body In Patient 157 2963
No Clinical Signs, Symptoms or Conditions 151 6617
Eye Injury 144 266
No Known Impact Or Consequence To Patient 135 257
Inflammation 134 1232
Iritis 99 1075
Blurred Vision 78 200
Loss of Vision 75 441
Corneal Edema 75 929
No Consequences Or Impact To Patient 73 1171
Pain 68 801
Intraocular Pressure, Delayed, Uncontrolled 63 64
Macular Edema 54 420
Hemorrhage/Bleeding 44 44
Uveitis 42 652
Insufficient Information 40 284
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 162
Eye Pain 39 39
No Information 38 38
Adhesion(s) 36 646
Corneal Decompensation 32 32
Endophthalmitis 27 881
Visual Disturbances 27 27
Failure of Implant 23 23
Intraocular Pressure Decreased 20 142
Headache 19 19
Vitreous Hemorrhage 18 18
Patient Problem/Medical Problem 14 14
Therapeutic Response, Decreased 13 13
Discomfort 13 13
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
Red Eye(s) 10 133
Hypopyon 9 131
Glaucoma 9 9
Fibrosis 9 9
Capsular Bag Tear 8 130
Scar Tissue 8 8
Therapeutic Effects, Unexpected 8 8
Fluid Discharge 6 6
Complaint, Ill-Defined 6 6
Reaction 5 5
Vitritis 5 127
No Patient Involvement 5 5
Nausea 5 5
Hypersensitivity/Allergic reaction 5 5
Microcystic Edema 4 4
Corneal Touch 4 4
Obstruction/Occlusion 4 4
Vomiting 4 4
Excessive Tear Production 4 4
Injury 4 4
Vitrectomy 3 3
UGH (Uveitis Glaucoma Hyphema) Syndrome 3 3
Device Embedded In Tissue or Plaque 3 3
Swelling/ Edema 3 3
Bacterial Infection 3 3
Conjunctivitis 3 247
Emotional Changes 3 3
Itching Sensation 3 3
Keratitis 3 125
Low Blood Pressure/ Hypotension 3 3
Unspecified Infection 3 3
Retinal Detachment 3 3
Local Reaction 2 2
Retinal Tear 2 2
Thrombus 2 2
Swelling 2 2
Vitreous Loss 2 2
Corneal Stromal Edema 2 2
Flashers 2 2
Vitreous Floaters 2 2
Host-Tissue Reaction 2 2
Erosion 2 2
Cataract 2 2
Corneal Ulcer 2 2
Dehydration 2 2
Edema 2 2
Increased Sensitivity 2 2
Eye Infections 2 124
Irritability 2 2
Blood Loss 2 2
Corneal Infiltrates 2 2
Burning Sensation 2 2
Dizziness 1 1
Halo 1 1
Deformity/ Disfigurement 1 1
Inadequate Pain Relief 1 1
Numbness 1 1
Toxicity 1 1
Vitreous Detachment 1 1
Prolapse 1 1
Confusion/ Disorientation 1 1

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