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TPLC
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show TPLC since
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2024
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Device
pump, infusion, ophthalmic
Product Code
MRH
Regulation Number
880.5725
Device Class
2
Premarket Reviews
Manufacturer
Decision
GLAUKOS
SUBSTANTIALLY EQUIVALENT
1
MICROSURGICAL TECHNOLOGIES INC
SUBSTANTIALLY EQUIVALENT
1
NEW WORLD MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
SIGHT SCIENCES INC.,
SUBSTANTIALLY EQUIVALENT
1
SIGHT SCIENCES, INC.
SUBSTANTIALLY EQUIVALENT
6
MDR Year
MDR Reports
MDR Events
2017
28
28
2018
1
1
2019
2
2
2020
6
6
2021
2
2
2022
16
138
2023
31
31
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
33
33
Material Fragmentation
20
20
Detachment of Device or Device Component
20
142
Detachment Of Device Component
9
9
Use of Device Problem
6
6
Improper or Incorrect Procedure or Method
5
5
No Apparent Adverse Event
2
2
Insufficient Information
1
1
Material Split, Cut or Torn
1
1
Break
1
1
Use of Incorrect Control/Treatment Settings
1
1
Mechanical Problem
1
1
Stretched
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
24
146
No Known Impact Or Consequence To Patient
19
19
Eye Injury
13
13
Intraocular Pressure Increased
11
11
Hyphema
8
8
Visual Impairment
7
7
No Consequences Or Impact To Patient
6
6
Intraocular Pressure Decreased
5
5
Hypopyon
3
3
Inflammation
3
3
Intraocular Pressure, Delayed, Uncontrolled
3
3
Corneal Edema
2
2
Corneal Perforation
2
2
Retinal Injury
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Optical Tissue, Breakdown Of
1
1
Uveitis
1
1
Vitreous Hemorrhage
1
1
UGH (Uveitis Glaucoma Hyphema) Syndrome
1
1
Unspecified Eye / Vision Problem
1
1
Device Embedded In Tissue or Plaque
1
1
Retinal Detachment
1
1
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