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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device aid, surgical, viscoelastic
Regulation Description Intraocular fluid.
Product CodeLZP
Regulation Number 886.4275
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
8 21 11 16 13 29 21 17 11 1

Device Problems
No Known Device Problem 220
Foreign material present in device 100
Unknown (for use when the device problem is not known) 97
Contamination during use 72
Detachment of device component 58
No Information 56
Use of Device Issue 48
Connection issue 46
Reuse 36
Loose or intermittent connection 22
No code available 18
Delivery system failure 14
Other (for use when an appropriate device code cannot be identified) 14
Physical resistance 11
Device clogged 8
Difficult to advance 7
Detachment of device or device component 5
Inaccurate delivery 5
Break 4
Leak 4
Device operates differently than expected 4
Device handling issue 2
Failure to deliver 2
Infusion or flow issue 2
Component(s), broken 2
Foreign material 2
Haptic(s), broken 2
Entrapment of device or device component 2
Lens, deposits on 2
Sticking 2
Particulates 2
Device Difficult to Setup or Prepare 1
Product quality issue 1
Difficult to remove 1
Material opacification 1
Material rigid or stiff 1
Improper or incorrect procedure or method 1
Malfunction 1
Defective component 1
Fluid leak 1
Device expiration issue 1
Blockage within device or device component 1
Clumping in device or device ingredient 1
Component falling 1
Cutoff point 1
Improper flow or infusion 1
Packaging issue 1
Dislodged or dislocated 1
Device, removal of (non-implant) 1
Patient-device incompatibility 1
Contamination of device ingredient or reagent 1
Total Device Problems 889

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical Optics Inc (AMO) II Dec-12-2014
2 Advanced Medical Optics, Inc. I Dec-10-2008
3 Becton Dickinson and Company II Dec-16-2010
4 C.L.R. Medicals International, Inc. I Dec-20-2013

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