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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lens,intraocular,accommodative
Regulation Description Intraocular lens.
Product CodeNAA
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
6 4 3 1 4 0 0 0 0 0 0

Device Problems
Dislodged or dislocated 535
No Known Device Problem 301
Malposition of device 115
Break 39
No Information 22
Torn material 18
Positioning Issue 13
Bent 10
No code available 9
Device or device component damaged by another device 9
Device remains implanted 8
Lens, vaulting 7
Optical decentration 5
Lens replacement 5
Difficult to position 4
Material opacification 4
Lens, repositioning of 4
Use of Device Issue 4
Deployment issue 3
Material twisted 3
Size incorrect for patient 3
Implant, removal of 3
Plunger Override 2
Scratched material 2
Lens Issue, No Description 2
Difficult to fold or unfold 2
Haptic(s), broken 2
Haptic Damaged in Delivery System 2
Material discolored 2
Explanted 2
Buckled material 1
Suspect EMI 1
Lens, opacification of 1
Material integrity issue 1
Haptic(s), bent 1
Device operates differently than expected 1
Fracture 1
Lens (IOL), line, crease on 1
Lens (IOL), scratch, mark on 1
Mechanical jam 1
Material separation 1
Folded 1
Lens, discoloration of 1
Difficult to insert 1
Difficult to advance 1
Material rupture 1
Device damaged prior to use 1
Defective item 1
Other (for use when an appropriate device code cannot be identified) 1
Mechanical issue 1
Total Device Problems 1160

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bausch and Lomb, Incorporated II Jan-11-2012

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