• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 4

Device Problems
Device remains implanted 259
No Information 143
Dislodged or dislocated 130
No Known Device Problem 74
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
Lens Issue, No Description 15
Foreign material 15
Break 12
Nonstandard device or device component 10
Positioning Issue 9
No code available 8
Difficult to fold or unfold 8
Use of Device Issue 8
Lens (IOL), dislocated intraocular 8
Scratched material 6
Torn material 5
Foreign material present in device 5
Failure to fold 5
Mechanical issue 4
Patient-device incompatibility 4
Packaging issue 3
Optical decentration 3
Haptic(s), broken 3
Leak 3
Dissatisfaction 3
Defective item 3
User used incorrect product for intended use 2
Unknown (for use when the device problem is not known) 2
Defective component 2
Improper or incorrect procedure or method 2
Material rupture 2
Size incorrect for patient 2
Sticking 2
Unexpected therapeutic results 2
Crack 2
Lens, deposits on 2
Material integrity issue 2
Deployment issue 2
Folding Issue 2
Haptic, Stuck to Optic 1
Unfold, difficult to 1
Device markings issue 1
Component or accessory incompatibility 1
Overcorrection 1
Protective measure issue 1
Unintended movement 1
Therapeutic or diagnostic output failure 1
Material opacification 1
Difficult to position 1
Power calculation error due to software problem 1
Degraded 1
Lens, cloudy 1
Device inoperable 1
Unstable 1
Other (for use when an appropriate device code cannot be identified) 1
Component missing 1
Device damaged prior to use 1
Total Device Problems 964

-
-