Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 5
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 1

Device Problems
No Known Device Problem 21
No Information 16
Total Device Problems 37

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

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

-
-