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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
FCI (FRANCE CHIRURGIE INSTRUMENTATION)
  SUBSTANTIALLY EQUIVALENT 1
FCI (FRANCE CHIRURGIE INSTRUMENTATION) SAS
  SUBSTANTIALLY EQUIVALENT 2
KANEKA PHARMA AMERICA LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 16 16
Device Handling Problem 16 16
Material Separation 13 13
Material Puncture/Hole 12 12
Break 9 9
Leak/Splash 5 5
Detachment of Device or Device Component 5 5
Device Operates Differently Than Expected 5 5
Separation Problem 4 4
Inflation Problem 4 4
Device Dislodged or Dislocated 4 4
Entrapment of Device 3 3
Crack 3 3
Material Fragmentation 3 3
Component Missing 3 3
Fluid/Blood Leak 3 3
Material Split, Cut or Torn 2 2
Premature Separation 2 2
Improper or Incorrect Procedure or Method 2 2
Device Slipped 1 1
Cut In Material 1 1
Extrusion 1 1
Pressure Problem 1 1
Physical Resistance/Sticking 1 1
Device Damaged Prior to Use 1 1
Disassembly 1 1
Defective Component 1 1
Air Leak 1 1
Misassembled 1 1
Material Rupture 1 1
Packaging Problem 1 1
Partial Blockage 1 1
Failure to Advance 1 1
Flaked 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 21 21
Device Embedded In Tissue or Plaque 18 18
No Consequences Or Impact To Patient 14 14
Foreign Body In Patient 9 9
No Clinical Signs, Symptoms or Conditions 5 5
Hemorrhage/Bleeding 2 2
Excessive Tear Production 2 2

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