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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, extended wear
Regulation Description Soft (hydrophilic) contact lens.
Product CodeLPM
Regulation Number 886.5925
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
4 15 12 30 51 49 31 26 35 3

Device Problems
No Known Device Problem 166
No Information 136
Not Applicable 77
Disposable 41
Unknown (for use when the device problem is not known) 40
Defective item 4
Use of Device Issue 2
Contamination during use 2
Improper or incorrect procedure or method 1
Sticking 1
Lens, toric 1
Device operates differently than expected 1
Torn material 1
Total Device Problems 473

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 1 0 0 2 0 0 0 1 1 0
Class III 0 0 0 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ciba Vision Corporation II May-27-2010
2 Ciba Vision Corporation II Feb-15-2007
3 Cooper Vision Caribbean Corp. II Dec-15-2014
4 Intertrade Imports Inc. II Jan-12-2015
5 Kim's Trading Inc II Jun-04-2010
6 Vistakon III Sep-21-2010

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