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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gases used within eye to place pressure on detached retina
Product CodeLPO
Regulation Number 886.4270
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
1 3 0 2 0 0 0 0 0 0 0 0 1 2 0 2

MDR Year MDR Reports MDR Events
2014 9 9
2015 10 10
2016 15 15
2017 21 21
2018 22 22
2019 29 29
2020 18 18
2021 18 18
2022 97 97
2023 25 25
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 87 87
Gas Output Problem 39 39
Device Operates Differently Than Expected 22 22
Appropriate Term/Code Not Available 21 21
Failure to Deliver 20 20
No Flow 17 17
Gas/Air Leak 9 9
Short Fill 8 8
Insufficient Information 7 7
Therapeutic or Diagnostic Output Failure 6 6
Filling Problem 6 6
Device Inoperable 5 5
Unexpected Therapeutic Results 4 4
Defective Device 3 3
Air Leak 3 3
Sticking 3 3
Defective Component 2 2
Mechanical Problem 2 2
Delivery System Failure 2 2
Off-Label Use 2 2
Output Problem 2 2
Complete Blockage 2 2
Leak/Splash 1 1
Improper Device Output 1 1
Pressure Problem 1 1
No Pressure 1 1
Insufficient Flow or Under Infusion 1 1
Inaccurate Delivery 1 1
Difficult to Open or Close 1 1
Restricted Flow rate 1 1
Energy Output Problem 1 1
Material Separation 1 1
Display or Visual Feedback Problem 1 1
No Device Output 1 1
Improper Flow or Infusion 1 1
Failure to Power Up 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Intraocular Pressure Increased 62 62
No Known Impact Or Consequence To Patient 60 60
No Clinical Signs, Symptoms or Conditions 56 56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 40
Retinal Detachment 15 15
No Consequences Or Impact To Patient 14 14
No Patient Involvement 14 14
No Code Available 6 6
Loss of Vision 6 6
Visual Impairment 6 6
Intraocular Pressure Decreased 5 5
Eye Injury 5 5
Visual Disturbances 5 5
Vitreous Floaters 4 4
Inflammation 4 4
Retinal Tear 3 3
Hyperemia 3 3
No Information 3 3
Cataract 3 3
Pain 3 3
Blurred Vision 2 2
Corneal Edema 2 2
Insufficient Information 2 2
Conjunctivitis 2 2
Flashers 2 2
Fever 2 2
Retinal Injury 2 2
Obstruction/Occlusion 2 2
Eye Burn 2 2
Retinal Degeneration 2 2
Nausea 2 2
Corneal Clouding/Hazing 2 2
Discomfort 1 1
Vomiting 1 1
Swelling 1 1
Foreign Body In Patient 1 1
Reaction 1 1
Vitreous Hemorrhage 1 1
Tissue Damage 1 1
Ischemia 1 1
Endophthalmitis 1 1
Hyphema 1 1
Emotional Changes 1 1
Therapeutic Effects, Unexpected 1 1
Headache 1 1
Neuropathy 1 1

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