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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
6 4 3 1 4 0 0 0 0 0

Device Problems
Dislodged or dislocated 504
No Known Device Problem 283
Malposition of device 115
Break 38
No Information 22
Torn material 18
Positioning Issue 13
Bent 10
Device or device component damaged by another device 9
No code available 9
Device remains implanted 8
Lens, vaulting 7
Optical decentration 5
Lens replacement 5
Use of Device Issue 4
Lens, repositioning of 4
Material opacification 4
Difficult to position 3
Size incorrect for patient 3
Implant, removal of 3
Deployment issue 3
Material twisted 3
Scratched material 2
Lens Issue, No Description 2
Haptic Damaged in Delivery System 2
Plunger Override 2
Haptic(s), broken 2
Material discolored 2
Explanted 2
Difficult to fold or unfold 2
Fracture 1
Haptic(s), bent 1
Difficult to insert 1
Lens, discoloration of 1
Lens, opacification of 1
Material rupture 1
Material separation 1
Mechanical issue 1
Buckled material 1
Device operates differently than expected 1
Defective item 1
Other (for use when an appropriate device code cannot be identified) 1
Device damaged prior to use 1
Suspect EMI 1
Folded 1
Lens (IOL), line, crease on 1
Lens (IOL), scratch, mark on 1
Mechanical jam 1
Difficult to advance 1
Material integrity issue 1
Total Device Problems 1109

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