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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lens, intraocular, toric optics
Regulation Description Intraocular lens.
Product CodeMJP
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 0 0 0 2 5 5 3

Device Problems
Device remains implanted 259
No Information 143
Dislodged or dislocated 120
No Known Device Problem 67
Lens, malposition of 39
Lens (IOL), scratch, mark on 37
Device operates differently than expected 28
Lens replacement 26
Malposition of device 23
Lens (IOL), torn, split, cracked 21
Foreign material 15
Lens Issue, No Description 15
Break 12
Nonstandard device or device component 10
Positioning Issue 8
Difficult to fold or unfold 8
Lens (IOL), dislocated intraocular 8
No code available 8
Use of Device Issue 8
Scratched material 6
Torn material 5
Foreign material present in device 5
Failure to fold 5
Patient-device incompatibility 4
Optical decentration 3
Haptic(s), broken 3
Leak 3
Dissatisfaction 3
Defective item 3
Mechanical issue 3
Packaging issue 3
Folding Issue 2
Crack 2
Material rupture 2
User used incorrect product for intended use 2
Size incorrect for patient 2
Sticking 2
Unexpected therapeutic results 2
Improper or incorrect procedure or method 2
Defective component 2
Material integrity issue 2
Lens, deposits on 2
Unknown (for use when the device problem is not known) 2
Deployment issue 2
Overcorrection 1
Therapeutic or diagnostic output failure 1
Component missing 1
Degraded 1
Unfold, difficult to 1
Haptic, Stuck to Optic 1
Device inoperable 1
Unstable 1
Lens, cloudy 1
Unintended movement 1
Material opacification 1
Component or accessory incompatibility 1
Protective measure issue 1
Power calculation error due to software problem 1
Device damaged prior to use 1
Device markings issue 1
Difficult to position 1
Other (for use when an appropriate device code cannot be identified) 1
Total Device Problems 945

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