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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ring, endocapsular
Product CodeMRJ
Device Class 3

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

MDR Year MDR Reports MDR Events
2016 2 2
2017 1 1
2018 1 1
2022 2 2
2023 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 3 3
Component Missing 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Torn Material 1 1
Unintended Movement 1 1
Break 1 1
Material Fragmentation 1 1
Defective Component 1 1
Defective Device 1 1
Device Operates Differently Than Expected 1 1
Material Twisted/Bent 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Known Impact Or Consequence To Patient 3 3
Insufficient Information 3 3
Capsular Bag Tear 2 2
No Code Available 1 1

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