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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lens, contact, (disposable)
Regulation Description Soft (hydrophilic) contact lens.
Product CodeMVN
Regulation Number 886.5925
Device Class 2


Premarket Reviews
ManufacturerDecision
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 4
CIBA VISION
  SUBSTANTIALLY EQUIVALENT 6
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 2
INNOVA
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
OCULAR SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
SAUFLON PHARMACEUTICALS, LTD.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 62
No Information 18
Torn material 6
No code available 1
Improper or incorrect procedure or method 1
Total Device Problems 88

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

Recalls
Manufacturer Recall Class Date Posted
1 CooperVision Inc. II Dec-19-2013
2 CooperVision Inc. III Nov-09-2009
3 Johnson & Johnson Vision Care, Inc. III Jan-12-2012

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