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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lens, multifocal intraocular
Regulation Description Intraocular lens.
Product CodeMFK
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
13 12 14 9 10 9 9 5 3 11 0

Device Problems
No Known Device Problem 872
Device remains implanted 744
No Information 663
Lens replacement 276
Explanted 92
Use of Device Issue 88
Dissatisfaction 84
No code available 82
Nonstandard device or device component 79
Device operates differently than expected 63
Lens, multifocal 39
Malposition of device 37
Other (for use when an appropriate device code cannot be identified) 35
Lens (IOL), scratch, mark on 32
Optical decentration 29
Scratched material 28
Unintended movement 25
Size incorrect for patient 22
Break 18
Foreign material present in device 18
Dislodged or dislocated 15
Lens (IOL), dislocated intraocular 15
Lens, malposition of 14
Patient-device incompatibility 13
Torn material 13
Material opacification 9
Haptic(s), broken 9
Migration of device or device component 8
Unknown (for use when the device problem is not known) 8
Lens (IOL), torn, split, cracked 7
Haptic(s), bent 7
Haptic, Stuck to Optic 7
Lens, cloudy 6
Failure to unfold or unwrap 6
Haptic Issue, No Description 5
Crack 5
Detachment of device component 4
Lens, deposits on 4
Defective item 4
Replace 4
Defective component 4
Positioning Issue 4
Implant, removal of 3
Lens implant 3
Lens Issue, No Description 3
Difficult to fold or unfold 3
Difficult to deploy 3
Bubble(s) 3
Bent 3
Incorrect measurement 3
Lens, repositioning of 2
Difficult to position 2
Material puncture 2
Product quality issue 2
Foreign material 2
Lens (IOL), nicked, chipped 2
Unfold, difficult to 2
Device Issue 2
Invalid sensing 2
Sticking 2
Improper or incorrect procedure or method 2
Material Distortion 2
Device or device component damaged by another device 2
Flare or flash 1
Human-Device Interface Issue 1
Improper device output 1
Material deformation 1
Therapeutic or diagnostic output failure 1
Material rupture 1
Residue after decontamination 1
Implant breakage or physical damage 1
Tipover 1
Sharp/jagged/rough/etched/scratched 1
Wrinkled 1
Misshaped Lens (Warped, not round) 1
Folding Issue 1
Haptic, Kinked 1
Delivery system failure 1
Fracture 1
Difficult to insert 1
Kinked 1
Air leak 1
Dislocated 1
Degraded 1
Device remains activated 1
Difficult to remove 1
Mechanical issue 1
Particulates 1
Pitted 1
Total Device Problems 3573

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 1 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Laboratories, Inc II Feb-15-2007

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