• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
KANEKA PHARMA AMERICA LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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
Break 8 8
Use of Device Problem 8 8
Material Separation 8 8
Device Handling Problem 8 8
Material Puncture/Hole 6 6
Detachment of Device or Device Component 5 5
Separation Problem 4 4
Inflation Problem 4 4
Leak/Splash 4 4
Device Operates Differently Than Expected 3 3
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
Fluid Leak 2 2
Material Fragmentation 2 2
Flaked 1 1
Disassembly 1 1
Detachment Of Device Component 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Cut In Material 1 1
Failure to Advance 1 1
Material Rupture 1 1
Physical Resistance/Sticking 1 1
Pressure Problem 1 1
Device Slipped 1 1
Partial Blockage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13 13
Device Embedded In Tissue or Plaque 10 10
No Consequences Or Impact To Patient 10 10
Foreign Body In Patient 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Hemorrhage/Bleeding 2 2
Excessive Tear Production 1 1

-
-