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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 7

Device Problems
Device remains implanted 744
No Known Device Problem 689
No Information 662
Lens replacement 276
Explanted 92
Use of Device Issue 86
Dissatisfaction 84
Nonstandard device or device component 79
No code available 72
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 24
Break 17
Lens (IOL), dislocated intraocular 15
Foreign material present in device 14
Lens, malposition of 14
Dislodged or dislocated 14
Patient-device incompatibility 13
Unintended movement 10
Torn material 9
Material opacification 9
Haptic(s), broken 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
Lens, cloudy 6
Migration of device or device component 5
Haptic Issue, No Description 5
Defective component 4
Failure to unfold or unwrap 4
Defective item 4
Replace 4
Lens, deposits on 4
Difficult to fold or unfold 3
Bubble(s) 3
Bent 3
Crack 3
Size incorrect for patient 3
Implant, removal of 3
Lens implant 3
Lens Issue, No Description 3
Positioning Issue 3
Material Distortion 2
Lens (IOL), nicked, chipped 2
Unfold, difficult to 2
Device Issue 2
Invalid sensing 2
Sticking 2
Difficult to position 2
Product quality issue 2
Detachment of device component 2
Foreign material 2
Lens, repositioning of 2
Incorrect measurement 2
Mechanical issue 1
Fracture 1
Air leak 1
Degraded 1
Difficult to deploy 1
Dislocated 1
Device remains activated 1
Difficult to remove 1
Material rupture 1
Particulates 1
Pitted 1
Improper or incorrect procedure or method 1
Residue after decontamination 1
Tipover 1
Sharp/jagged/rough/etched/scratched 1
Implant breakage or physical damage 1
Misshaped Lens (Warped, not round) 1
Folding Issue 1
Haptic, Kinked 1
Human-Device Interface Issue 1
Improper device output 1
Material deformation 1
Therapeutic or diagnostic output failure 1
Flare or flash 1
Total Device Problems 3305

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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