Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 3

MDR Year MDR Reports MDR Events
2019 352 474
2020 197 807
2021 243 6709
2022 239 11951
2023 185 185
2024 107 107

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 581 7779
Malposition of Device 243 2805
Obstruction of Flow 110 2062
Break 107 5231
Insufficient Information 67 67
Device Dislodged or Dislocated 53 1273
Use of Device Problem 23 267
Patient-Device Incompatibility 21 21
Migration 17 17
Contamination 17 627
Appropriate Term/Code Not Available 12 12
Positioning Problem 11 11
Separation Failure 8 8
Therapeutic or Diagnostic Output Failure 8 8
Migration or Expulsion of Device 8 8
Improper or Incorrect Procedure or Method 7 7
Defective Device 6 6
No Apparent Adverse Event 6 6
Unexpected Therapeutic Results 6 6
Nonstandard Device 6 6
Activation, Positioning or Separation Problem 5 5
Difficult to Advance 5 5
Patient Device Interaction Problem 5 127
Separation Problem 4 4
Failure to Advance 4 4
Device Stenosis 4 4
Complete Blockage 4 4
Material Twisted/Bent 4 4
Difficult to Insert 4 4
Fracture 3 125
Failure to Eject 3 3
Device Appears to Trigger Rejection 3 3
Failure to Fire 3 3
Lack of Effect 2 2
Contamination /Decontamination Problem 2 124
Material Protrusion/Extrusion 2 2
Difficult or Delayed Activation 2 2
Material Integrity Problem 2 2
Increase in Pressure 2 2
Biocompatibility 2 2
Entrapment of Device 1 1
Off-Label Use 1 1
Excess Flow or Over-Infusion 1 1
Structural Problem 1 1
Output Problem 1 1
Activation Problem 1 1
Mechanical Jam 1 1
Intermittent Loss of Power 1 1
Human-Device Interface Problem 1 1
Retraction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Intraocular Pressure Increased 328 5209
Hyphema 186 3968
No Clinical Signs, Symptoms or Conditions 161 6627
Foreign Body In Patient 138 2944
Visual Impairment 109 1939
Inflammation 104 1202
Eye Injury 85 207
No Code Available 84 84
Iritis 71 1047
Corneal Edema 60 914
No Consequences Or Impact To Patient 52 1150
Macular Edema 50 416
No Known Impact Or Consequence To Patient 50 172
Insufficient Information 48 292
Blurred Vision 47 169
Eye Pain 40 40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 162
Adhesion(s) 39 649
Uveitis 34 644
Loss of Vision 34 400
Pain 34 767
Corneal Decompensation 29 29
Intraocular Pressure Decreased 25 147
Endophthalmitis 20 874
Visual Disturbances 17 17
Headache 16 16
Failure of Implant 14 14
Vitreous Hemorrhage 13 13
Intraocular Pressure, Delayed, Uncontrolled 12 13
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 9 131
Hemorrhage/Bleeding 8 8
Therapeutic Response, Decreased 8 8
Scar Tissue 8 8
Red Eye(s) 8 131
Corneal Clouding/Hazing 8 8
Corneal Abrasion 7 7
Glaucoma 7 7
Discomfort 7 7
Fluid Discharge 6 6
No Information 6 6
Hypopyon 5 127
Therapeutic Effects, Unexpected 4 4
Hypersensitivity/Allergic reaction 4 4
Device Embedded In Tissue or Plaque 4 4
Fibrosis 4 4
Excessive Tear Production 4 4

-
-