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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 1
KANEKA CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Handling Problem 23
Use of Device Problem 23
Material Separation 16
Material Puncture / Hole 11
Material Deformation 5
Separation Problem 3
Material Split, Cut or Torn 2
Balloon 2
Crack 2
Material Rupture 1
Catheter 1
Device Operates Differently Than Expected 1
Break 1
Cut In Material 1
Inflation Problem 1
Decrease in Pressure 1
Leak / Splash 1
Burst Container or Vessel 1
Defective Component 1
Detachment of Device or device Component 1
Total Device Problems 98


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