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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
FCI (FRANCE CHIRURGIE INSTRUMENTATION) SAS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
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
Break 6 6
Detachment of Device or Device Component 4 4
Separation Problem 4 4
Premature Separation 2 2
Material Split, Cut or Torn 2 2
Improper or Incorrect Procedure or Method 2 2
Crack 2 2
Entrapment of Device 2 2
Material Fragmentation 2 2
Leak/Splash 2 2
Material Puncture/Hole 1 1
Material Rupture 1 1
Material Separation 1 1
Use of Device Problem 1 1
Flaked 1 1
Fluid/Blood Leak 1 1
Defective Component 1 1
Cut In Material 1 1
Failure to Advance 1 1
Pressure Problem 1 1
Device Handling Problem 1 1
Detachment Of Device Component 1 1
Physical Resistance/Sticking 1 1
Partial Blockage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 8 8
Foreign Body In Patient 5 5
No Clinical Signs, Symptoms or Conditions 5 5
No Known Impact Or Consequence To Patient 4 4
Device Embedded In Tissue or Plaque 3 3
Hemorrhage/Bleeding 2 2
Excessive Tear Production 1 1

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