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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 5

Device Problems
Size incorrect for patient 2292
No code available 1483
Explanted 1064
Lens, vaulting 943
Device operates differently than expected 706
Device remains implanted 242
Other (for use when an appropriate device code cannot be identified) 215
Torn material 169
Dislodged or dislocated 146
No Known Device Problem 122
Unknown (for use when the device problem is not known) 122
Unintended movement 116
Lens (IOL), torn, split, cracked 111
No Information 73
Break 52
Tears, rips, holes in device, device material 47
Failure to deploy 28
Haptic(s), broken 15
Optical decentration 14
Defective item 12
Lens Damaged in Delivery System 11
Foreign material present in device 10
Lens Stuck in Delivery System 9
Improper or incorrect procedure or method 9
Difficult to fold or unfold 9
Foreign material 8
Lens, repositioning of 8
Lens, stuck in cartridge 8
Failure to expand 8
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
Patient-device incompatibility 5
Fracture 4
Haptic(s), fractured 4
Use of Device Issue 4
Difficult to position 4
Misfocusing 3
Lens (IOL), dislocated intraocular 3
Difficult to remove 3
Crack 3
Lens, deposits on 3
Deployment issue 3
Unfold, difficult to 3
Sticking 3
Malposition of device 3
Incomplete or missing packaging 2
Lens (IOL), line, crease on 2
Plunger Override 2
Device handling issue 2
Bent 2
Entrapment of device or device component 2
Difficult to deploy 2
Difficult to insert 2
Haptic(s), bent 2
Mechanical jam 2
Lens, cloudy 1
Emergency table stop failure 1
Shelf life exceeded 1
Slippage of device or device component 1
Undercorrection 1
Delivered as unsterile product 1
Particulates 1
Lens, opacification of 1
Migration of device or device component 1
Difficult to advance 1
Difficult to open or close 1
Lens Issue, No Description 1
Item contaminated during manufacturing or shipping 1
Manufacturing or shipping issue associated with device 1
Material deformation 1
Material twisted 1
Implant, removal of 1
Tear, rip or hole in device packaging 1
Folded 1
Total Device Problems 8178

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