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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 663
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
Haptic(s), broken 15
No Information 15
No Known Device Problem 12
Optical decentration 12
Defective item 11
Lens Damaged in Delivery System 11
Lens Stuck in Delivery System 9
Lens, stuck in cartridge 8
Lens, repositioning of 8
Foreign material 8
Haptic Damaged in Delivery System 6
Lens (IOL), defective, problem not specified 5
Lens (IOL), scratch, mark on 5
Dislocated 5
Fracture 4
Haptic(s), fractured 4
Positioning Issue 4
Foreign material present in device 4
Device operates differently than expected 3
Unfold, difficult to 3
Lens, deposits on 3
Difficult to fold or unfold 3
Malposition of device 3
Failure to unfold or unwrap 3
Lens (IOL), dislocated intraocular 3
Sticking 2
Lens (IOL), line, crease on 2
Difficult to position 2
Difficult to remove 2
Haptic(s), bent 2
Difficult to insert 2
Plunger Override 2
Scratched material 2
Difficult to advance 1
Difficult to open or close 1
Material twisted 1
Lens Issue, No Description 1
Lens, cloudy 1
Lens, opacification of 1
Particulates 1
Emergency table stop failure 1
Crack 1
Undercorrection 1
Slippage of device or device component 1
Folded 1
Implant, removal of 1
Total Device Problems 4720

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