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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lenses, soft contact, daily wear
Regulation Description Soft (hydrophilic) contact lens.
Product CodeLPL
Regulation Number 886.5925
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 3
ALCON
  SUBSTANTIALLY EQUIVALENT 3
ART OPTICAL CONTACT LENS, INC.
  SUBSTANTIALLY EQUIVALENT 4
ASPECT VISION CARE, LTD.
  SUBSTANTIALLY EQUIVALENT 5
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 15
BENZ RESEARCH AND DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 10
CIBA VISION
  SUBSTANTIALLY EQUIVALENT 14
CONTAMAC LTD.
  SUBSTANTIALLY EQUIVALENT 4
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 29
INNOVA
  SUBSTANTIALLY EQUIVALENT 5
INTEROJO INC.
  SUBSTANTIALLY EQUIVALENT 2
I-SEE VISION TECHNOLOGY INC
  SUBSTANTIALLY EQUIVALENT 3
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 8
MENICON CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
OCULAR SCIENCES
  SUBSTANTIALLY EQUIVALENT 8
SAFILENS, S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
SAUFLON PHARMACEUTICALS, LTD.
  SUBSTANTIALLY EQUIVALENT 3
UNILENS CORP., USA
  SUBSTANTIALLY EQUIVALENT 14
VISCO VISION INC.
  SUBSTANTIALLY EQUIVALENT 1
VISTAKON
  SUBSTANTIALLY EQUIVALENT 13
WESTCON CONTACT LENS CO.
  SUBSTANTIALLY EQUIVALENT 1
X-CEL CONTACTS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Disposable 587
No Known Device Problem 99
No Information 57
Unknown (for use when the device problem is not known) 19
Not Applicable 15
Torn material 9
Device operates differently than expected 8
Patient-device incompatibility 5
Use of Device Issue 5
Product quality issue 4
Defective item 4
No code available 4
Tears, rips, holes in device, device material 3
Difficult to remove 3
Improper or incorrect procedure or method 3
Break 2
Component missing 2
Naturally worn 2
Material integrity issue 1
Lens, aspherical 1
Other (for use when an appropriate device code cannot be identified) 1
Material rupture 1
Sticking 1
Tap water, use of 1
Packaging issue 1
Total Device Problems 838

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 1 1 0 0 0 0
Class II 1 0 0 0 1 1 2 0 1 0
Class III 0 0 1 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bausch & Lomb Inc Irb II Nov-04-2015
2 CIBA Vision Puerto Rico, Inc. II Apr-13-2011
3 Ciba Vision Corporation II May-09-2007
4 Cooper Vision Caribbean Corp. III Oct-24-2014
5 Cooper Vision Caribbean Corp. II Jan-03-2013
6 CooperVision Inc. I Oct-14-2011
7 Coopervision Inc. I Jan-11-2012
8 Eyezone II Jan-11-2012
9 Johnson & Johnson Vision Care, Inc. II May-17-2013
10 Vistakon III Sep-18-2009

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