• 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, phakic
Product CodeMTA
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
0 7 3 5 4 2 1 2 2 0 2

Device Problems
Size incorrect for patient 1536
No code available 1481
Explanted 1064
Lens, vaulting 943
Device remains implanted 242
Device operates differently than expected 218
Other (for use when an appropriate device code cannot be identified) 215
Torn material 168
Unknown (for use when the device problem is not known) 122
Unintended movement 115
Lens (IOL), torn, split, cracked 111
No Known Device Problem 68
Break 52
Tears, rips, holes in device, device material 47
No Information 42
Dislodged or dislocated 37
Haptic(s), broken 15
Optical decentration 12
Defective item 12
Lens Damaged in Delivery System 11
Failure to deploy 10
Lens Stuck in Delivery System 9
Lens, stuck in cartridge 8
Foreign material present in device 8
Foreign material 8
Lens, repositioning of 8
Difficult to fold or unfold 7
Positioning Issue 7
Haptic Damaged in Delivery System 6
Failure to unfold or unwrap 6
Dislocated 5
Lens (IOL), defective, problem not specified 5
Lens (IOL), scratch, mark on 5
Scratched material 5
Fracture 4
Haptic(s), fractured 4
Difficult to position 4
Sticking 3
Difficult to remove 3
Misfocusing 3
Crack 3
Lens, deposits on 3
Failure to expand 3
Patient-device incompatibility 3
Deployment issue 3
Malposition of device 3
Lens (IOL), dislocated intraocular 3
Unfold, difficult to 3
Plunger Override 2
Lens (IOL), line, crease on 2
Device handling issue 2
Bent 2
Entrapment of device or device component 2
Difficult to insert 2
Haptic(s), bent 2
Use of Device Issue 2
Undercorrection 1
Slippage of device or device component 1
Delivered as unsterile product 1
Particulates 1
Lens, opacification of 1
Lens, cloudy 1
Difficult to deploy 1
Emergency table stop failure 1
Difficult to advance 1
Difficult to open or close 1
Item contaminated during manufacturing or shipping 1
Material twisted 1
Mechanical jam 1
Folded 1
Improper or incorrect procedure or method 1
Implant, removal of 1
Lens Issue, No Description 1
Total Device Problems 6686

-
-