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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
Explanted 1063
Lens, vaulting 942
No code available 923
Size incorrect for patient 662
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 80
Unintended movement 78
Tears, rips, holes in device, device material 47
Break 39
No Information 15
Haptic(s), broken 15
Optical decentration 12
No Known Device Problem 12
Lens Damaged in Delivery System 11
Defective item 11
Lens Stuck in Delivery System 9
Foreign material 8
Lens, stuck in cartridge 8
Lens, repositioning of 8
Haptic Damaged in Delivery System 6
Lens (IOL), defective, problem not specified 5
Dislocated 5
Lens (IOL), scratch, mark on 5
Foreign material present in device 4
Haptic(s), fractured 4
Positioning Issue 4
Fracture 4
Device operates differently than expected 3
Unfold, difficult to 3
Lens (IOL), dislocated intraocular 3
Lens, deposits on 3
Malposition of device 3
Failure to unfold or unwrap 3
Difficult to fold or unfold 3
Sticking 2
Plunger Override 2
Difficult to position 2
Difficult to insert 2
Scratched material 2
Lens (IOL), line, crease on 2
Haptic(s), bent 2
Difficult to remove 2
Undercorrection 1
Lens, cloudy 1
Material twisted 1
Lens, opacification of 1
Difficult to open or close 1
Particulates 1
Emergency table stop failure 1
Difficult to advance 1
Slippage of device or device component 1
Crack 1
Implant, removal of 1
Lens Issue, No Description 1
Folded 1
Total Device Problems 4719

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