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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device vitrectomy, instrument cutter
Regulation Description Vitreous aspiration and cutting instrument.
Product CodeMLZ
Regulation Number 886.4150
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED MEDICAL OPTICS
  SUBSTANTIALLY EQUIVALENT 1
ALCON
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Issue 15
Tip breakage 12
Failure to cut 4
Metal shedding debris 1
Total Device Problems 32

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