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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 2

Device Problems
Size incorrect for patient 1660
No code available 1481
Explanted 1064
Lens, vaulting 943
Device operates differently than expected 368
Device remains implanted 242
Other (for use when an appropriate device code cannot be identified) 215
Torn material 169
Unknown (for use when the device problem is not known) 122
Unintended movement 116
Lens (IOL), torn, split, cracked 111
No Known Device Problem 77
Break 52
Dislodged or dislocated 51
Tears, rips, holes in device, device material 47
No Information 43
Haptic(s), broken 15
Failure to deploy 14
Optical decentration 13
Defective item 12
Lens Damaged in Delivery System 11
Lens Stuck in Delivery System 9
Difficult to fold or unfold 9
Foreign material 8
Lens, repositioning of 8
Foreign material present in device 8
Lens, stuck in cartridge 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
Scratched material 5
Lens (IOL), scratch, mark on 5
Failure to expand 4
Improper or incorrect procedure or method 4
Fracture 4
Haptic(s), fractured 4
Difficult to position 4
Misfocusing 3
Difficult to remove 3
Crack 3
Lens, deposits on 3
Unfold, difficult to 3
Malposition of device 3
Sticking 3
Lens (IOL), dislocated intraocular 3
Patient-device incompatibility 3
Deployment issue 3
Device handling issue 2
Incomplete or missing packaging 2
Lens (IOL), line, crease on 2
Plunger Override 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
Implant, removal of 1
Folded 1
Difficult to advance 1
Difficult to open or close 1
Lens Issue, No Description 1
Item contaminated during manufacturing or shipping 1
Material deformation 1
Material twisted 1
Mechanical jam 1
Total Device Problems 7000

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