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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 4

Device Problems
No Known Device Problem 945
Device remains implanted 744
No Information 661
Lens replacement 276
Explanted 92
No code available 89
Use of Device Issue 88
Dissatisfaction 84
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
Scratched material 32
Optical decentration 29
Size incorrect for patient 28
Unintended movement 27
Foreign material present in device 19
Break 19
Torn material 18
Dislodged or dislocated 15
Lens (IOL), dislocated intraocular 15
Lens, malposition of 14
Patient-device incompatibility 13
Migration of device or device component 9
Material opacification 9
Haptic(s), broken 9
Unknown (for use when the device problem is not known) 8
Failure to unfold or unwrap 7
Lens (IOL), torn, split, cracked 7
Haptic, Stuck to Optic 7
Haptic(s), bent 7
Crack 7
Lens, cloudy 6
Haptic Issue, No Description 5
Defective item 4
Defective component 4
Replace 4
Detachment of device component 4
Lens, deposits on 4
Positioning Issue 4
Difficult to fold or unfold 3
Difficult to deploy 3
Bubble(s) 3
Bent 3
Incorrect measurement 3
Sticking 3
Implant, removal of 3
Lens implant 3
Lens Issue, No Description 3
Lens (IOL), nicked, chipped 2
Unfold, difficult to 2
Device Issue 2
Invalid sensing 2
Improper or incorrect procedure or method 2
Kinked 2
Lens, repositioning of 2
Difficult to position 2
Material puncture 2
Product quality issue 2
Foreign material 2
Material Distortion 2
Device or device component damaged by another device 2
Delivery system failure 1
Human-Device Interface Issue 1
Improper device output 1
Material deformation 1
Therapeutic or diagnostic output failure 1
Flare or flash 1
Device handling issue 1
Fracture 1
Difficult to insert 1
Air leak 1
Dislocated 1
Degraded 1
Device remains activated 1
Particulates 1
Pitted 1
Mechanical issue 1
Material rupture 1
Difficult to remove 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
Total Device Problems 3677

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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