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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device microscope, operating & accessories, ac-powered, ophthalmic
Regulation Description Surgical microscope and accessories.
Product CodeHRM
Regulation Number 878.4700
Device Class 1


Premarket Reviews
ManufacturerDecision
ALCON
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 1
LUMENIS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Component falling 5
Loose or intermittent connection 4
Loss of power 3
User used incorrect product for intended use 3
Inadequate training 3
Device inoperable 3
Device displays error message 3
Device operates differently than expected 3
Inadequate lighting 2
No code available 2
Detachment of device component 1
No Known Device Problem 1
Optical issue 1
No Information 1
Dislodged or dislocated 1
Connection issue 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Misfocusing 1
Unintended system motion 1
Disconnection 1
Total Device Problems 42

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research, Ltd. II Aug-21-2015

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