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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, irrigation, ocular surgery
Regulation Description Ocular surgery irrigation device.
Product CodeKYG
Regulation Number 886.4360
Device Class 1

Device Problems
Knife 47
Dull, Blunt 40
Failure to Cut 6
Device Contamination with Chemical or Other Material 5
Trocar 5
Fitting Problem 4
Torn Material 3
Detachment of Device or Device Component 3
Probe 3
Scratched Material 2
Insufficient Information 2
Device Operates Differently Than Expected 2
Syringe 2
Detachment Of Device Component 2
Material Deformation 2
Break 1
Device Dislodged or Dislocated 1
Tube 1
Use of Device Problem 1
Device Issue 1
Aspiration Issue 1
Tip 1
Fluid Leak 1
Adverse Event Without Identified Device or Use Problem 1
Device Misassembled During Manufacturing /Shipping 1
Device Operational Issue 1
Infusion or Flow Problem 1
Total Device Problems 140


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