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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
Regulation Description Intraocular gas.
Product CodeLPO
Regulation Number 886.4270
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
1 2 0 8 6 6

MDR Year MDR Reports MDR Events
2021 18 18
2022 97 97
2023 25 25
2024 9 9
2025 55 55
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 134 134
Gas Output Problem 31 31
Appropriate Term/Code Not Available 19 19
Failure to Deliver 11 11
Short Fill 8 8
Gas/Air Leak 3 3
Off-Label Use 2 2
Defective Component 2 2
Restricted Flow rate 1 1
Insufficient Information 1 1
Use of Device Problem 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Intraocular Pressure Increased 69 69
No Clinical Signs, Symptoms or Conditions 52 52
Glaucoma 43 43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 40
Retinal Detachment 12 12
Visual Impairment 5 5
Intraocular Pressure Decreased 5 5
Inflammation 4 4
Vitreous Floaters 4 4
Cataract 3 3
Visual Disturbances 3 3
Eye Injury 3 3
Loss of Vision 3 3
Retinal Tear 3 3
Corneal Clouding/Hazing 2 2
Retinal Degeneration 2 2
Obstruction/Occlusion 2 2
Eye Burn 2 2
Retinal Injury 2 2
Fever 2 2
Flashers 2 2
Conjunctivitis 2 2
Insufficient Information 2 2
Corneal Edema 2 2
Blurred Vision 2 2
Hyperemia 2 2
Nausea 1 1
Endophthalmitis 1 1
Ischemia 1 1
Pain 1 1
Vitreous Hemorrhage 1 1
Hyphema 1 1
Pupillary Block 1 1
Eye Pain 1 1

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