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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)
2020
2021
2022
2023
2024
2025
6
6
5
6
4
4
MDR Year
MDR Reports
MDR Events
2020
197
807
2021
243
6709
2022
239
11951
2023
185
185
2024
163
163
2025
65
65
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
440
7638
Malposition of Device
219
2781
Break
121
5245
Obstruction of Flow
94
2046
Insufficient Information
59
59
Device Dislodged or Dislocated
46
1266
Use of Device Problem
22
266
Migration
22
22
Contamination
19
629
Defective Device
7
7
Separation Failure
7
7
Positioning Problem
7
7
Migration or Expulsion of Device
7
7
Patient-Device Incompatibility
6
6
Difficult to Advance
5
5
Device Stenosis
5
5
Failure to Eject
4
4
Separation Problem
4
4
Nonstandard Device
4
4
Failure to Advance
4
4
Material Twisted/Bent
4
4
Fracture
4
126
Improper or Incorrect Procedure or Method
4
4
Appropriate Term/Code Not Available
3
3
No Apparent Adverse Event
3
3
Difficult to Insert
3
3
Complete Blockage
3
3
Lack of Effect
2
2
Biocompatibility
2
2
Contamination /Decontamination Problem
2
124
Activation, Positioning or Separation Problem
2
2
Patient Device Interaction Problem
1
1
Firing Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Excess Flow or Over-Infusion
1
1
Power Problem
1
1
Unsealed Device Packaging
1
123
Particulates
1
1
Device Appears to Trigger Rejection
1
1
Retraction Problem
1
1
Mechanical Jam
1
1
Difficult or Delayed Activation
1
1
Material Deformation
1
1
Detachment of Device or Device Component
1
1
Difficult to Open or Close
1
1
Human-Device Interface Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Intraocular Pressure Increased
279
5159
No Clinical Signs, Symptoms or Conditions
185
6651
Hyphema
158
3940
Foreign Body In Patient
113
2919
Eye Injury
89
211
Inflammation
86
1184
Visual Impairment
84
1914
Corneal Edema
60
914
Insufficient Information
59
303
Iritis
58
1034
Blurred Vision
53
175
Macular Edema
50
416
Adhesion(s)
46
656
Eye Pain
44
44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
39
161
No Consequences Or Impact To Patient
37
1013
Uveitis
37
647
Intraocular Pressure Decreased
30
152
Loss of Vision
22
388
Endophthalmitis
19
873
Visual Disturbances
17
17
Pain
17
749
Corneal Decompensation
15
15
No Known Impact Or Consequence To Patient
14
136
No Code Available
13
13
Headache
10
10
Vitreous Hemorrhage
9
9
Dry Eye(s)
8
8
Foreign Body Sensation in Eye
7
7
Hypersensitivity/Allergic reaction
7
7
UGH (Uveitis Glaucoma Hyphema) Syndrome
7
7
Capsular Bag Tear
7
129
Scar Tissue
6
6
Red Eye(s)
6
128
Hemorrhage/Bleeding
6
6
Corneal Clouding/Hazing
6
6
Glaucoma
6
6
Failure of Implant
5
5
Itching Sensation
5
5
Excessive Tear Production
5
5
Hypopyon
5
127
Discomfort
5
5
Eye Infections
5
127
Fluid Discharge
5
5
Swelling/ Edema
4
4
Keratitis
4
126
Therapeutic Response, Decreased
4
4
Corneal Abrasion
4
4
Device Embedded In Tissue or Plaque
4
4
Intraocular Pressure, Delayed, Uncontrolled
3
3
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