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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device scissors, ophthalmic
Regulation Description Manual ophthalmic surgical instrument.
Product CodeHNF
Regulation Number 886.4350
Device Class 1


Premarket Reviews
ManufacturerDecision
ALCON
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROLINE PENTAX, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Component(s), broken 2
Other (for use when an appropriate device code cannot be identified) 2
Tip breakage 2
Device inoperable 1
Dull 1
Cut in material 1
Detachment of device or device component 1
Device operational issue 1
No code available 1
Unintended system motion 1
Material separation 1
Sticking 1
Total Device Problems 15

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