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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 9

Device Problems
Device remains implanted 744
No Known Device Problem 714
No Information 662
Lens replacement 276
Explanted 92
Use of Device Issue 86
Dissatisfaction 84
Nonstandard device or device component 79
No code available 73
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 25
Break 17
Lens (IOL), dislocated intraocular 15
Dislodged or dislocated 14
Foreign material present in device 14
Lens, malposition of 14
Patient-device incompatibility 13
Torn material 10
Unintended movement 10
Haptic(s), broken 9
Material opacification 9
Unknown (for use when the device problem is not known) 8
Haptic, Stuck to Optic 7
Lens (IOL), torn, split, cracked 7
Haptic(s), bent 7
Migration of device or device component 6
Lens, cloudy 6
Haptic Issue, No Description 5
Defective component 4
Defective item 4
Lens, deposits on 4
Failure to unfold or unwrap 4
Size incorrect for patient 4
Replace 4
Difficult to fold or unfold 3
Bubble(s) 3
Detachment of device component 3
Crack 3
Bent 3
Lens implant 3
Implant, removal of 3
Lens Issue, No Description 3
Positioning Issue 3
Material Distortion 2
Unfold, difficult to 2
Invalid sensing 2
Device Issue 2
Lens (IOL), nicked, chipped 2
Lens, repositioning of 2
Incorrect measurement 2
Foreign material 2
Sticking 2
Difficult to position 2
Product quality issue 2
Device remains activated 1
Particulates 1
Pitted 1
Material rupture 1
Difficult to remove 1
Fracture 1
Degraded 1
Difficult to deploy 1
Dislocated 1
Mechanical issue 1
Air leak 1
Tipover 1
Sharp/jagged/rough/etched/scratched 1
Residue after decontamination 1
Improper or incorrect procedure or method 1
Implant breakage or physical damage 1
Misshaped Lens (Warped, not round) 1
Folding Issue 1
Haptic, Kinked 1
Flare or flash 1
Human-Device Interface Issue 1
Improper device output 1
Material deformation 1
Therapeutic or diagnostic output failure 1
Total Device Problems 3336

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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