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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lens, guide, intraocular
Regulation Description Intraocular lens guide.
Product CodeKYB
Regulation Number 886.4300
Device Class 1


Premarket Reviews
ManufacturerDecision
ADVANCED MEDICAL OPTICS
  SUBSTANTIALLY EQUIVALENT 1
ALCON
  SUBSTANTIALLY EQUIVALENT 5
ALLERGAN, INC.
  SUBSTANTIALLY EQUIVALENT 3
BAUSCH & LOMB, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 2
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DUCKWORTH & KENT, LTD.
  SUBSTANTIALLY EQUIVALENT 2
STAAR
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Lens (IOL), torn, split, cracked 238
Lens Damaged in Delivery System 206
Haptic Damaged in Delivery System 174
Lens, damaged by cartridge 139
Other (for use when an appropriate device code cannot be identified) 104
Haptic(s), bent 92
Crack 80
Break 72
No Known Device Problem 63
Foreign material present in device 51
No code available 44
Device or device component damaged by another device 37
Plunger Override 32
Haptic(s), broken 28
Lens, stuck in cartridge 26
Use of Device Issue 25
Material deformation 25
No Information 25
Difficult to deploy 23
Lens Stuck in Delivery System 19
Failure to deploy 18
Split 18
Inaccurate delivery 17
Device remains implanted 15
Device operates differently than expected 15
Delivery system failure 14
Torn material 13
Unknown (for use when the device problem is not known) 13
Haptic, Kinked 13
Bent 12
Foreign material 11
Mechanical jam 11
Plunger Issue, No Description 10
Difficult to insert 8
Material fragmentation 7
Defective item 7
Stretched 7
Scratched material 7
Haptic Stuck in Delivery System 6
Physical resistance 6
Haptic, Stuck to Optic 5
Lens, malposition of 5
Packaging issue 5
Difficult to advance 4
Deployment issue 4
Buckled material 4
Haptic(s), detached 4
Device damaged prior to use 4
Failure to deliver 4
Lens replacement 3
Sticking 3
Nozzle Tip, Stressed, Split 3
Lens, difficulty loading into cartridge 3
Failure to advance 3
Haptic Issue, No Description 3
Malposition of device 3
Lens (IOL), scratch, mark on 3
Device Issue 2
Folding Issue 2
Delivery System Issue, No Description 2
Haptic, Missing 2
Tip breakage 2
Material separation 2
Hole in material 2
Dry, failure to 2
Entrapment of device or device component 2
Mislabeled 2
Misplacement 2
Detachment of device or device component 2
Flare or flash 2
Difficult to open or close 1
Positioning Issue 1
Device handling issue 1
Material Distortion 1
Material Protrusion 1
Plunger not Aligned Properly 1
Traditional use 1
Aspiration issue 1
Delivered as unsterile product 1
Device emits odor 1
Particulates 1
Difficult to position 1
Device Difficult to Setup or Prepare 1
User used incorrect product for intended use 1
Material puncture 1
Lens, repositioning of 1
Melted 1
Optical decentration 1
Replace 1
Material rigid or stiff 1
Material rupture 1
Rupture due to damage from surgical instrument 1
Failure to fold 1
Burst 1
Collapse 1
Component(s), worn 1
Fracture 1
Slippage of device or device component 1
Tears, rips, holes in device, device material 1
Fitting problem 1
Total Device Problems 1850

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 0 1 1 0 0 0 0 0 0 1 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 Sep-23-2008
2 Staar Surgical Co. II Jun-14-2016
3 Volk Optical Inc II Jul-14-2009

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