• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
No Known Device Problem 63
Crack 48
Device or device component damaged by another device 37
Plunger Override 32
Break 30
Haptic(s), broken 28
Lens, stuck in cartridge 26
No Information 25
Use of Device Issue 24
No code available 20
Lens Stuck in Delivery System 19
Inaccurate delivery 17
Device remains implanted 15
Split 13
Unknown (for use when the device problem is not known) 13
Haptic, Kinked 13
Delivery system failure 13
Foreign material 11
Plunger Issue, No Description 10
Device operates differently than expected 10
Foreign material present in device 10
Mechanical jam 10
Torn material 8
Difficult to insert 8
Haptic Stuck in Delivery System 6
Haptic, Stuck to Optic 5
Defective item 5
Bent 5
Difficult to deploy 5
Lens, malposition of 5
Scratched material 5
Packaging issue 5
Buckled material 4
Difficult to advance 4
Deployment issue 4
Haptic(s), detached 4
Physical resistance 4
Failure to deliver 4
Haptic Issue, No Description 3
Lens, difficulty loading into cartridge 3
Nozzle Tip, Stressed, Split 3
Malposition of device 3
Lens (IOL), scratch, mark on 3
Device damaged prior to use 3
Lens replacement 3
Material fragmentation 3
Failure to deploy 3
Sticking 3
Mislabeled 2
Misplacement 2
Dry, failure to 2
Hole in material 2
Tip breakage 2
Device Issue 2
Delivery System Issue, No Description 2
Folding Issue 2
Haptic, Missing 2
Detachment of device or device component 2
Flare or flash 2
Material deformation 2
Positioning Issue 1
Traditional use 1
Aspiration issue 1
Difficult to open or close 1
Device handling issue 1
Plunger not Aligned Properly 1
Failure to advance 1
Overdelivery 1
Fitting problem 1
Component missing 1
Implant, removal of 1
Optical decentration 1
Failure to fold 1
Fracture 1
Component(s), worn 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
Tears, rips, holes in device, device material 1
Lens, repositioning of 1
Replace 1
Material rigid or stiff 1
Material rupture 1
Rupture due to damage from surgical instrument 1
Material separation 1
Slippage of device or device component 1
Total Device Problems 1604

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 0 1 1 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 Sep-23-2008
2 Volk Optical Inc II Jul-14-2009

-
-