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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
4 15 12 30 51 49 14

Device Problems
No Information 127
No Known Device Problem 47
Disposable 41
Unknown (for use when the device problem is not known) 40
Defective item 4
Lens, toric 1
Total Device Problems 260

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 0 0 2 0 0 0
Class III 0 0 0 1 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 Kim's Trading Inc II Jun-04-2010
4 Vistakon III Sep-21-2010

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