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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 1084
Explanted 1063
Lens, vaulting 942
Size incorrect for patient 790
Device remains implanted 242
Other (for use when an appropriate device code cannot be identified) 215
Unknown (for use when the device problem is not known) 122
Lens (IOL), torn, split, cracked 110
Torn material 93
Unintended movement 87
Tears, rips, holes in device, device material 47
Break 45
No Information 17
Haptic(s), broken 15
Optical decentration 12
Defective item 12
No Known Device Problem 12
Lens Damaged in Delivery System 11
Lens Stuck in Delivery System 9
Lens, stuck in cartridge 8
Lens, repositioning of 8
Foreign material 8
Positioning Issue 7
Haptic Damaged in Delivery System 6
Lens (IOL), defective, problem not specified 5
Lens (IOL), scratch, mark on 5
Dislocated 5
Failure to unfold or unwrap 5
Difficult to fold or unfold 4
Fracture 4
Haptic(s), fractured 4
Foreign material present in device 4
Device operates differently than expected 3
Unfold, difficult to 3
Sticking 3
Lens, deposits on 3
Lens (IOL), dislocated intraocular 3
Malposition of device 3
Difficult to position 2
Difficult to remove 2
Difficult to insert 2
Haptic(s), bent 2
Lens (IOL), line, crease on 2
Plunger Override 2
Scratched material 2
Material twisted 1
Difficult to advance 1
Difficult to open or close 1
Lens Issue, No Description 1
Lens, opacification of 1
Lens, cloudy 1
Bent 1
Emergency table stop failure 1
Crack 1
Slippage of device or device component 1
Particulates 1
Folded 1
Implant, removal of 1
Undercorrection 1
Total Device Problems 5047

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