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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device fluid, intraocular
Regulation Description Intraocular fluid.
Product CodeLWL
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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