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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
13 12 14 9 10 9 9 5 3 4

Device Problems
Device remains implanted 744
No Information 662
No Known Device Problem 661
Lens replacement 276
Explanted 92
Use of Device Issue 86
Dissatisfaction 84
Nonstandard device or device component 79
No code available 70
Device operates differently than expected 61
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 21
Break 16
Lens (IOL), dislocated intraocular 15
Lens, malposition of 14
Dislodged or dislocated 14
Foreign material present in device 14
Patient-device incompatibility 13
Haptic(s), broken 9
Material opacification 9
Torn material 9
Unintended movement 8
Unknown (for use when the device problem is not known) 8
Lens (IOL), torn, split, cracked 7
Haptic, Stuck to Optic 7
Haptic(s), bent 7
Lens, cloudy 6
Migration of device or device component 5
Haptic Issue, No Description 5
Defective item 4
Defective component 4
Failure to unfold or unwrap 4
Replace 4
Lens, deposits on 4
Bubble(s) 3
Implant, removal of 3
Lens implant 3
Lens Issue, No Description 3
Positioning Issue 3
Lens (IOL), nicked, chipped 2
Material Distortion 2
Device Issue 2
Invalid sensing 2
Unfold, difficult to 2
Detachment of device component 2
Crack 2
Difficult to fold or unfold 2
Foreign material 2
Bent 2
Lens, repositioning of 2
Incorrect measurement 2
Sticking 2
Difficult to position 2
Product quality issue 2
Device remains activated 1
Particulates 1
Pitted 1
Improper or incorrect procedure or method 1
Material rupture 1
Size incorrect for patient 1
Difficult to remove 1
Mechanical issue 1
Air leak 1
Fracture 1
Degraded 1
Difficult to deploy 1
Dislocated 1
Implant breakage or physical damage 1
Tipover 1
Sharp/jagged/rough/etched/scratched 1
Residue after decontamination 1
Flare or flash 1
Human-Device Interface Issue 1
Improper device output 1
Material deformation 1
Misshaped Lens (Warped, not round) 1
Folding Issue 1
Haptic, Kinked 1
Therapeutic or diagnostic output failure 1
Total Device Problems 3264

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