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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device probe, lachrymal
Product CodeHNL
Regulation Number 886.4350
Device Class 1

MDR Year MDR Reports MDR Events
2014 6 6
2016 1 1
2019 2 2
2020 1 1
2021 3 3
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 12 12
Detachment Of Device Component 2 2
Material Fragmentation 2 2
Device Or Device Fragments Location Unknown 1 1
Material Deformation 1 1
Material Twisted/Bent 1 1
Disconnection 1 1
Entrapment of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 4 4
No Known Impact Or Consequence To Patient 3 3
No Consequences Or Impact To Patient 3 3
No Information 2 2
Eye Infections 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Inflammation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Quest Medical, Inc. II Apr-02-2015
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