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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
ATRION MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EAGLE VISION, INC.
  SUBSTANTIALLY EQUIVALENT 2
HURRICANE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
POREX SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Use of Device Issue 9
Device handling issue 9
Material separation 5
Material deformation 4
Defective component 1
Device operates differently than expected 1
Burst 1
Fracture 1
Inflation issue 1
Leak 1
Decrease in pressure 1
Material rupture 1
Total Device Problems 35

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