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TPLC
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show TPLC since
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Device
fluid, intraocular
Regulation Description
Intraocular fluid.
Product Code
LWL
Regulation Number
886.4275
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
1
3
1
11
2
0
MDR Year
MDR Reports
MDR Events
2020
7
7
2021
12
12
2022
13
13
2023
18
18
2024
16
16
2025
20
20
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
61
61
Appropriate Term/Code Not Available
8
8
Patient-Device Incompatibility
5
5
Migration or Expulsion of Device
3
3
Air/Gas in Device
2
2
Break
1
1
Off-Label Use
1
1
Use of Device Problem
1
1
Particulates
1
1
Packaging Problem
1
1
Product Quality Problem
1
1
Material Protrusion/Extrusion
1
1
Unexpected Therapeutic Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
26
26
Visual Impairment
17
17
Blurred Vision
13
13
Retinal Detachment
13
13
Loss of Vision
10
10
Cataract
7
7
Intraocular Pressure Increased
6
6
Toxic Anterior Segment Syndrome (TASS)
6
6
Retinal Degeneration
5
5
Inflammation
5
5
Hemorrhage/Bleeding
4
4
Intraocular Pressure Decreased
4
4
Retinal Tear
3
3
Hypopyon
3
3
Vitreous Hemorrhage
3
3
Endophthalmitis
3
3
Unspecified Eye / Vision Problem
3
3
Uveitis
2
2
Eye Pain
2
2
Pulmonary Edema
2
2
Visual Disturbances
2
2
Dry Eye(s)
2
2
Ischemia
2
2
Macular Edema
2
2
Vitreous Detachment
2
2
Eye Burn
1
1
Cardiac Arrest
1
1
Retinal Injury
1
1
Foreign Body Reaction
1
1
Capsular Bag Tear
1
1
Optical Nerve Damage
1
1
Microcystic Edema
1
1
Laceration(s)
1
1
Dizziness
1
1
Scar Tissue
1
1
Eye Injury
1
1
Failure of Implant
1
1
Chemosis
1
1
Corneal Edema
1
1
Vitreous Floaters
1
1
Red Eye(s)
1
1
Hypoxia
1
1
Pupillary Block
1
1
Hypersensitivity/Allergic reaction
1
1
Stacking Breaths
1
1
Irritability
1
1
Foreign Body Sensation in Eye
1
1
Infiltration into Tissue
1
1
Headache
1
1
Corneal Scar
1
1
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