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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
2019 8 8
2020 2 2
2021 6 6
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Separation Problem 4 4
Break 4 4
Improper or Incorrect Procedure or Method 2 2
Leak/Splash 2 2
Entrapment of Device 2 2
Detachment of Device or Device Component 2 2
Premature Separation 2 2
Crack 2 2
Pressure Problem 1 1
Physical Resistance/Sticking 1 1
Material Puncture/Hole 1 1
Material Separation 1 1
Partial Blockage 1 1
Failure to Advance 1 1
Use of Device Problem 1 1
Fluid/Blood Leak 1 1
Device Handling Problem 1 1
Material Rupture 1 1

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

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