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TPLC
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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 Code
OGO
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
66
66
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
570
7768
Malposition of Device
229
2791
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
319
5200
Hyphema
182
3964
No Clinical Signs, Symptoms or Conditions
153
6619
Foreign Body In Patient
131
2937
Visual Impairment
107
1937
Inflammation
102
1200
Eye Injury
84
206
No Code Available
84
84
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
49
415
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
23
145
Endophthalmitis
19
873
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
9
131
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
Device Embedded In Tissue or Plaque
4
4
Fibrosis
4
4
Excessive Tear Production
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
Eye Infections
2
124
Irritability
2
2
No Patient Involvement
2
2
Nervous System Injury
1
1
Not Applicable
1
1
Zonular Dehiscence
1
1
Vitrectomy
1
1
Vitreous Detachment
1
1
Needle Stick/Puncture
1
1
Prolapse
1
1
Toxic Anterior Segment Syndrome (TASS)
1
123
Implant Pain
1
1
Unspecified Eye / Vision Problem
1
1
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
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