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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fluid, intraocular
Product CodeLWL
Regulation Number 886.4275
Device Class 3

Premarket Approvals (PMA)
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
1 2 2 0 1 0 1 3 1 11 0

MDR Year MDR Reports MDR Events
2014 3 3
2015 3 3
2016 13 13
2017 3 3
2018 6 6
2019 2 2
2020 7 7
2021 12 12
2022 13 13
2023 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 41 41
Insufficient Information 10 10
Appropriate Term/Code Not Available 8 8
Migration or Expulsion of Device 4 4
Patient-Device Incompatibility 4 4
Device Operates Differently Than Expected 2 2
Air/Gas in Device 2 2
Use of Device Problem 2 2
Break 1 1
Overcorrection 1 1
Device Contamination with Chemical or Other Material 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Nonstandard Device 1 1
Particulates 1 1
Difficult to Remove 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 24 24
Retinal Detachment 12 12
Visual Impairment 9 9
No Code Available 8 8
Loss of Vision 6 6
Hemorrhage/Bleeding 5 5
Cataract 5 5
Blurred Vision 5 5
Foreign Body In Patient 4 4
Intraocular Pressure Increased 4 4
Endophthalmitis 3 3
Macular Edema 3 3
Hypopyon 3 3
Visual Disturbances 3 3
Retinal Degeneration 3 3
Inflammation 3 3
Intraocular Pressure Decreased 3 3
Toxic Anterior Segment Syndrome (TASS) 2 2
Unspecified Eye / Vision Problem 2 2
Eye Pain 2 2
Complaint, Ill-Defined 2 2
No Known Impact Or Consequence To Patient 2 2
Reaction 2 2
Retinal Tear 2 2
Swelling 2 2
Optical Nerve Damage 2 2
Pulmonary Edema 2 2
Ischemia 2 2
Itching Sensation 1 1
Laceration(s) 1 1
Myocardial Infarction 1 1
Eye Injury 1 1
Vitreous Floaters 1 1
Foreign Body Reaction 1 1
Foreign Body Sensation in Eye 1 1
Microcystic Edema 1 1
Emotional Changes 1 1
Stacking Breaths 1 1
Air Embolism 1 1
Cardiac Arrest 1 1
Chemosis 1 1
Corneal Edema 1 1
Dry Eye(s) 1 1
Red Eye(s) 1 1
Retinal Injury 1 1
Pain 1 1
Paralysis 1 1
Hypoxia 1 1
Therapeutic Effects, Unexpected 1 1
Uveitis 1 1
Scar Tissue 1 1
Weakness 1 1
Discomfort 1 1
Irritability 1 1
Fibrosis 1 1
Injury 1 1
Deformity/ Disfigurement 1 1

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