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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 1222
Explanted 1063
Lens, vaulting 942
Size incorrect for patient 895
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
Torn material 113
Lens (IOL), torn, split, cracked 110
Unintended movement 97
Break 49
Tears, rips, holes in device, device material 47
No Information 20
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
Failure to unfold or unwrap 6
Dislocated 5
Difficult to fold or unfold 5
Lens (IOL), defective, problem not specified 5
Foreign material present in device 5
Lens (IOL), scratch, mark on 5
Fracture 4
Haptic(s), fractured 4
Difficult to position 4
Difficult to remove 3
Lens (IOL), dislocated intraocular 3
Malposition of device 3
Lens, deposits on 3
Scratched material 3
Device operates differently than expected 3
Unfold, difficult to 3
Sticking 3
Lens (IOL), line, crease on 2
Plunger Override 2
Bent 2
Difficult to insert 2
Haptic(s), bent 2
Lens, opacification of 1
Lens, cloudy 1
Emergency table stop failure 1
Entrapment of device or device component 1
Crack 1
Folded 1
Implant, removal of 1
Undercorrection 1
Slippage of device or device component 1
Particulates 1
Deployment issue 1
Difficult to advance 1
Difficult to open or close 1
Lens Issue, No Description 1
Material twisted 1
Total Device Problems 5337

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