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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)
2017 2018 2019 2020 2021 2022
5 9 6 6 6 5

MDR Year MDR Reports MDR Events
2017 298 298
2018 511 511
2019 352 474
2020 197 807
2021 243 6709
2022 198 9592

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 794 7260
Malposition of Device 234 2308
Insufficient Information 173 173
Obstruction of Flow 126 1712
Break 81 4961
Device Dislodged or Dislocated 50 1026
Patient-Device Incompatibility 46 46
Use of Device Problem 39 283
Appropriate Term/Code Not Available 35 35
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 16 504
Activation, Positioning or Separation Problem 11 11
No Apparent Adverse Event 9 9
Therapeutic or Diagnostic Output Failure 8 8
Nonstandard Device 8 8
Unexpected Therapeutic Results 8 8
Complete Blockage 7 7
Defective Device 7 7
Material Protrusion/Extrusion 6 6
Migration 6 6
Patient Device Interaction Problem 5 127
Unintended Movement 5 5
Failure to Fire 4 4
Failure to Advance 4 4
Difficult to Insert 4 4
Increase in Pressure 4 4
Device Appears to Trigger Rejection 3 3
Bent 3 3
Fracture 3 125
Difficult or Delayed Positioning 3 3
Positioning Failure 3 3
Separation Failure 3 3
Difficult or Delayed Activation 3 3
Physical Resistance 3 3
Extrusion 3 3
Optical Obstruction 3 3
Contamination /Decontamination Problem 3 125
Material Integrity Problem 3 3
Separation Problem 3 3
Physical Resistance/Sticking 2 2
Mechanical Jam 2 2
Device Handling Problem 2 2
Difficult to Advance 2 2
Difficult to Open or Close 2 2
Biocompatibility 2 2
Entrapment of Device 2 2
Material Fragmentation 2 2
Mechanical Problem 2 2
Occlusion Within Device 2 2
Unsealed Device Packaging 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
Premature Activation 1 1
Excess Flow or Over-Infusion 1 1
Filling Problem 1 1
Fluid/Blood Leak 1 1
Detachment Of Device Component 1 1
Failure to Discharge 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
Output Problem 1 1
Power Problem 1 1
Mechanics Altered 1 1
No Flow 1 1
Material Twisted/Bent 1 1
Detachment of Device or Device Component 1 1
Intermittent Loss of Power 1 1
Activation Problem 1 1
Firing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Intraocular Pressure Increased 466 4737
Hyphema 208 3502
No Code Available 197 197
Visual Impairment 147 1733
No Known Impact Or Consequence To Patient 135 257
Eye Injury 126 248
Foreign Body In Patient 124 2320
Inflammation 107 1083
No Clinical Signs, Symptoms or Conditions 105 5839
Iritis 87 1063
Loss of Vision 74 440
No Consequences Or Impact To Patient 73 1171
Pain 66 799
Blurred Vision 64 186
Intraocular Pressure, Delayed, Uncontrolled 63 64
Corneal Edema 62 794
Macular Edema 44 410
Hemorrhage/Bleeding 43 43
No Information 38 38
Uveitis 37 647
Corneal Decompensation 30 30
Visual Disturbances 26 26
Eye Pain 26 26
Endophthalmitis 25 879
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 146
Insufficient Information 23 267
Failure of Implant 23 23
Headache 17 17
Adhesion(s) 16 504
Vitreous Hemorrhage 15 15
Intraocular Pressure Decreased 15 137
Patient Problem/Medical Problem 14 14
Therapeutic Response, Decreased 13 13
Discomfort 11 11
Tissue Damage 11 11
Corneal Abrasion 11 11
Corneal Clouding/Hazing 9 9
Hypopyon 9 131
Dry Eye(s) 8 8
Therapeutic Effects, Unexpected 8 8
Scar Tissue 8 8
Red Eye(s) 8 131
Fibrosis 8 8
Foreign Body Sensation in Eye 7 7
Complaint, Ill-Defined 6 6
Reaction 5 5
Capsular Bag Tear 5 127
No Patient Involvement 5 5
Glaucoma 5 5
Hypersensitivity/Allergic reaction 5 5
Nausea 5 5
Vitritis 5 127
Microcystic Edema 4 4
Corneal Touch 4 4
Injury 4 4
Fluid Discharge 3 3
Vitrectomy 3 3
Device Embedded In Tissue or Plaque 3 3
Swelling/ Edema 3 3
Emotional Changes 3 3
Conjunctivitis 3 247
Bacterial Infection 3 3
Low Blood Pressure/ Hypotension 3 3
Vomiting 3 3
Keratitis 3 125
Unspecified Infection 3 3
Itching Sensation 2 2
Local Reaction 2 2
Retinal Detachment 2 2
Burning Sensation 2 2
Retinal Tear 2 2
Swelling 2 2
Thrombus 2 2
Erosion 2 2
Host-Tissue Reaction 2 2
Edema 2 2
Corneal Ulcer 2 2
Dehydration 2 2
Increased Sensitivity 2 2
Blood Loss 2 2
Irritability 2 2
Corneal Infiltrates 2 2
Excessive Tear Production 2 2
Halo 1 1
Toxicity 1 1
Obstruction/Occlusion 1 1
Confusion/ Disorientation 1 1
Deformity/ Disfigurement 1 1
Inadequate Pain Relief 1 1
Numbness 1 1
Implant Pain 1 1
Not Applicable 1 1
Toxic Anterior Segment Syndrome (TASS) 1 123
UGH (Uveitis Glaucoma Hyphema) Syndrome 1 1
Unspecified Eye / Vision Problem 1 1
Abrasion 1 1
Wound Dehiscence 1 1
High Blood Pressure/ Hypertension 1 1
Hyperemia 1 1
Erythema 1 1

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