• 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 intraocular lens
Regulation Description Intraocular lens.
Product CodeHQL
Regulation Number 886.3600
Device Class 3


Premarket Reviews
ManufacturerDecision
STAAR
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
51 48 33 44 32 38 30 18 27 49 4

Device Problems
No Known Device Problem 4471
Lens (IOL), torn, split, cracked 2336
Packaging issue 2257
Leak 2220
Haptic(s), bent 1214
Device remains implanted 1112
No code available 1054
Haptic(s), broken 1045
No Information 859
Other (for use when an appropriate device code cannot be identified) 820
Explanted 681
Haptic Damaged in Delivery System 651
Malposition of device 587
Lens replacement 539
Break 536
Material opacification 477
Use of Device Issue 414
Lens Damaged in Delivery System 413
Lens Stuck in Delivery System 405
Torn material 339
Lens, vaulting 304
Scratched material 264
Foreign material present in device 247
Unknown (for use when the device problem is not known) 246
Failure to deliver 213
Sticking 205
Bent 194
Dislodged or dislocated 179
Lens, stuck in cartridge 147
Device operates differently than expected 146
Crack 137
Difficult to deploy 123
Detachment of device component 111
Inaccurate delivery 111
Unintended movement 107
Defective item 104
Failure to deploy 102
Lens (IOL), scratch, mark on 101
Difficult to fold or unfold 95
Haptic, Kinked 91
Lens (IOL), dislocated intraocular 89
Device or device component damaged by another device 86
Plunger Override 81
Haptic(s), detached 79
Optical decentration 75
Failure to fold 75
Haptic Stuck in Delivery System 75
Lens, malposition of 65
Lens, opacification of 64
Failure to unfold or unwrap 63
Lens Issue, No Description 56
Fracture 52
Lens, repositioning of 50
Lens, cloudy 49
Foreign material 49
Deployment issue 49
Lens, deposits on 48
Size incorrect for patient 48
Implant, removal of 47
Positioning Issue 44
Device Issue 42
Difficult to position 35
Mechanical jam 35
Haptic, Stuck to Optic 34
Dissatisfaction 34
Haptic Issue, No Description 33
Lens, damaged by cartridge 31
Haptic, Missing 28
Device handling issue 28
Failure to advance 28
Entrapment of device or device component 28
Difficult to insert 28
Inadequate instructions for healthcare professional 25
Material discolored 25
Premature deployment 25
Split 24
Calcified 23
Kinked 22
Material Distortion 21
Component missing 19
Lens, difficulty loading into cartridge 18
Material deformation 17
Material twisted 17
Lens (IOL), defective, problem not specified 16
Power calculation error due to software problem 16
Haptic(s), fractured 16
Fitting problem 15
Tears, rips, holes in device, device material 15
Implant, repositioning of 15
Delivery system failure 15
Device markings issue 15
Patient-device incompatibility 14
Difficult to advance 14
Wrinkled 14
Physical resistance 14
Sediment, precipitate or deposit in device or device ingredient 13
Lens (IOL), line, crease on 11
Defective component 11
Material rigid or stiff 11
Incorrect measurement 11
Total Device Problems 27757

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 2 0 0
Class II 0 0 1 2 3 0 3 3 3 2 0
Class III 0 0 0 0 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AMO Puerto Rico Manufacturing, Inc. II Aug-26-2014
2 AMO Puerto Rico Manufacturing, Inc. II Mar-03-2014
3 Aaren Scientific, Incorporated II Mar-20-2015
4 Aaren Scientific, Incorporated III Feb-22-2012
5 Abbott Medical Optics Inc (AMO) II Mar-09-2013
6 Abbott Medical Optics Inc (AMO) II Nov-23-2011
7 Abbott Medical Optics Inc (AMO) II Jan-12-2010
8 Abbott Medical Optics Inc. (AMO) II Sep-21-2016
9 Alcon Research, Ltd. II Sep-01-2016
10 Alcon Research, Ltd. I Nov-25-2015
11 Alcon Research, Ltd. I Aug-07-2015
12 Bausch & Lomb Inc II Jan-11-2010
13 Bausch & Lomb Inc II Sep-09-2009
14 Bausch & Lomb Surgical, Inc. II Jul-20-2015
15 Bausch & Lomb Surgical, Inc. II Feb-20-2014
16 Hoya Surgical Optics, Inc. II Jul-14-2011
17 Medicel Ag II Aug-20-2013
18 Staar Surgical Co. II Jul-17-2013
19 Staar Surgical Co. II Jun-29-2011
20 Tekia, Inc. II Nov-06-2015

-
-