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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 68
No Known Device Problem 63
Break 58
No code available 43
Foreign material present in device 41
Device or device component damaged by another device 37
Plunger Override 32
Haptic(s), broken 28
Lens, stuck in cartridge 26
No Information 25
Use of Device Issue 25
Material deformation 23
Lens Stuck in Delivery System 19
Difficult to deploy 18
Inaccurate delivery 17
Split 17
Device remains implanted 15
Failure to deploy 15
Device operates differently than expected 15
Delivery system failure 14
Torn material 13
Haptic, Kinked 13
Unknown (for use when the device problem is not known) 13
Bent 12
Foreign material 11
Plunger Issue, No Description 10
Mechanical jam 10
Difficult to insert 8
Scratched material 7
Material fragmentation 7
Physical resistance 6
Haptic Stuck in Delivery System 6
Haptic, Stuck to Optic 5
Lens, malposition of 5
Packaging issue 5
Defective item 5
Device damaged prior to use 4
Difficult to advance 4
Haptic(s), detached 4
Failure to deliver 4
Buckled material 4
Deployment issue 4
Haptic Issue, No Description 3
Failure to advance 3
Malposition of device 3
Lens replacement 3
Nozzle Tip, Stressed, Split 3
Lens, difficulty loading into cartridge 3
Lens (IOL), scratch, mark on 3
Sticking 3
Misplacement 2
Material separation 2
Hole in material 2
Device Issue 2
Entrapment of device or device component 2
Folding Issue 2
Detachment of device or device component 2
Flare or flash 2
Tip breakage 2
Haptic, Missing 2
Delivery System Issue, No Description 2
Dry, failure to 2
Mislabeled 2
Plunger not Aligned Properly 1
Component missing 1
Particulates 1
Melted 1
Difficult to open or close 1
Device Difficult to Setup or Prepare 1
Obstruction within device 1
Material puncture 1
Replace 1
Failure to fold 1
Delivered as unsterile product 1
Tears, rips, holes in device, device material 1
Optical decentration 1
Fracture 1
Burst 1
Overdelivery 1
Collapse 1
Implant, removal of 1
Difficult to position 1
Slippage of device or device component 1
Rupture due to damage from surgical instrument 1
Component(s), worn 1
Material rupture 1
Positioning Issue 1
Traditional use 1
Material Distortion 1
Material rigid or stiff 1
Device handling issue 1
Material Protrusion 1
User used incorrect product for intended use 1
Device emits odor 1
Total Device Problems 1793

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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