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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device microscope, surgical
Regulation Description Surgical microscope and accessories.
Product CodeEPT
Regulation Number 878.4700
Device Class 1


Premarket Reviews
ManufacturerDecision
ALCON
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Electrical issue 11
Improper or incorrect procedure or method 4
Overheating of device or device component 3
Device Issue 3
Device operates differently than expected 3
Use of Device Issue 3
Maintenance does not comply to manufacturers recommendations 2
Device maintenance issue 2
Circuit Failure 2
Use of Incorrect Control Settings 2
Disconnection 2
Computer software issue 1
Failure to conduct 1
Mechanical issue 1
Material frayed 1
Defective item 1
Device displays error message 1
Detachment of device or device component 1
Product quality issue 1
Inadequate service 1
Defective component 1
Material integrity issue 1
No Known Device Problem 1
Problem with software installation 1
Unintended movement 1
Misassembled by Users 1
No Information 1
No code available 1
Noise, Audible 1
Dislodged or dislocated 1
Electrical shorting 1
Total Device Problems 57

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 3 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Carl Zeiss Meditec Inc II Jan-14-2011
2 Carl Zeiss Meditec, Inc. II May-31-2013
3 Carl Zeiss Meditec, Inc. II Oct-24-2011
4 Carl Zeiss Meditec, Inc. II Sep-23-2011

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