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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 3

Device Problems
Size incorrect for patient 1874
No code available 1482
Explanted 1064
Lens, vaulting 943
Device operates differently than expected 504
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 94
Dislodged or dislocated 89
No Information 55
Break 52
Tears, rips, holes in device, device material 47
Failure to deploy 19
Haptic(s), broken 15
Optical decentration 13
Defective item 12
Lens Damaged in Delivery System 11
Foreign material present in device 10
Lens Stuck in Delivery System 9
Difficult to fold or unfold 9
Foreign material 8
Lens, repositioning of 8
Lens, stuck in cartridge 8
Positioning Issue 7
Haptic Damaged in Delivery System 6
Failure to unfold or unwrap 6
Failure to expand 6
Dislocated 5
Lens (IOL), defective, problem not specified 5
Lens (IOL), scratch, mark on 5
Improper or incorrect procedure or method 5
Scratched material 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
Patient-device incompatibility 3
Deployment issue 3
Sticking 3
Malposition of device 3
Unfold, difficult to 3
Lens (IOL), line, crease on 2
Plunger Override 2
Incomplete or missing packaging 2
Device handling issue 2
Bent 2
Entrapment of device or device component 2
Difficult to insert 2
Haptic(s), bent 2
Lens, cloudy 1
Difficult to deploy 1
Emergency table stop failure 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
Mechanical jam 1
Implant, removal of 1
Folded 1
Total Device Problems 7432

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