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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lacrimal stents and intubation sets
Definition Lacrimal stents and intubations sets are intended to repair the lacrimal drainage system. Lacrimal stents and intubations sets are indicated for, but limited to, the treatment of epiphora in infants and adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant.
Product CodeOKS
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ANODYNE
  SUBSTANTIALLY EQUIVALENT - KIT 1
ARMADILLO BIOMEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
DCS SURGICAL INC
  SUBSTANTIALLY EQUIVALENT 1
FCI (FRANCE CHIRURGIE INSTRUMENTATION)
  SUBSTANTIALLY EQUIVALENT 1
FCI (FRANCE CHIRURGIE INSTRUMENTATION) SAS
  SUBSTANTIALLY EQUIVALENT 2
FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION)
  SUBSTANTIALLY EQUIVALENT 3
FRANCE CHIRURGAE INSTRUMENTATION
  SUBSTANTIALLY EQUIVALENT 1
HIROYASU HIGUCHI
  SUBSTANTIALLY EQUIVALENT 1
KANEKA PHARMA AMERICA LLC
  SUBSTANTIALLY EQUIVALENT 1
LJT SURGICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 8 8
2015 14 14
2016 21 21
2017 18 18
2018 6 6
2019 8 8
2020 2 2
2021 6 6
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 24 24
Device Handling Problem 24 24
Material Separation 18 18
Material Puncture/Hole 13 13
Break 12 12
Inflation Problem 6 6
Component Missing 6 6
Detachment of Device or Device Component 5 5
Device Operates Differently Than Expected 5 5
Leak/Splash 5 5
Crack 4 4
Device Dislodged or Dislocated 4 4
Material Fragmentation 4 4
Material Deformation 4 4
Separation Problem 4 4
Material Rupture 3 3
Improper or Incorrect Procedure or Method 3 3
Physical Resistance 3 3
Entrapment of Device 3 3
Fluid/Blood Leak 3 3
Bent 2 2
Burst Container or Vessel 2 2
Defective Component 2 2
Premature Separation 2 2
Material Split, Cut or Torn 2 2
Physical Resistance/Sticking 1 1
Packaging Problem 1 1
Pressure Problem 1 1
Cut In Material 1 1
Failure to Advance 1 1
Extrusion 1 1
Device Damaged Prior to Use 1 1
Device Slipped 1 1
Difficult to Remove 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Partial Blockage 1 1
Disassembly 1 1
Air Leak 1 1
Flaked 1 1
Misassembled 1 1
Decrease in Pressure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 27 27
Device Embedded In Tissue or Plaque 27 27
No Consequences Or Impact To Patient 25 25
Foreign Body In Patient 11 11
Excessive Tear Production 9 9
No Clinical Signs, Symptoms or Conditions 5 5
Hemorrhage/Bleeding 2 2
Blood Loss 1 1
No Information 1 1

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