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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
0 7 3 5 4 2 1 2 2 0

Device Problems
No code available 1449
Size incorrect for patient 1221
Explanted 1064
Lens, vaulting 943
Device remains implanted 242
Other (for use when an appropriate device code cannot be identified) 215
Torn material 162
Unknown (for use when the device problem is not known) 122
Unintended movement 114
Lens (IOL), torn, split, cracked 111
Break 52
Tears, rips, holes in device, device material 47
No Information 29
Haptic(s), broken 15
Optical decentration 12
No Known Device Problem 12
Defective item 12
Lens Damaged in Delivery System 11
Dislodged or dislocated 10
Lens Stuck in Delivery System 9
Lens, stuck in cartridge 8
Foreign material 8
Lens, repositioning of 8
Foreign material present in device 7
Positioning Issue 7
Haptic Damaged in Delivery System 6
Difficult to fold or unfold 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
Device operates differently than expected 4
Fracture 4
Haptic(s), fractured 4
Difficult to position 4
Sticking 3
Lens (IOL), dislocated intraocular 3
Difficult to remove 3
Lens, deposits on 3
Failure to deploy 3
Malposition of device 3
Unfold, difficult to 3
Lens (IOL), line, crease on 2
Plunger Override 2
Deployment issue 2
Bent 2
Difficult to insert 2
Haptic(s), bent 2
Lens, opacification of 1
Lens, cloudy 1
Crack 1
Emergency table stop failure 1
Entrapment of device or device component 1
Slippage of device or device component 1
Misfocusing 1
Particulates 1
Implant, removal of 1
Undercorrection 1
Difficult to advance 1
Difficult to open or close 1
Material twisted 1
Folded 1
Lens Issue, No Description 1
Total Device Problems 5992

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