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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
51 48 33 44 32 38 30 18 27 18

Device Problems
No Known Device Problem 4166
Lens (IOL), torn, split, cracked 2331
Packaging issue 2252
Leak 2215
Haptic(s), bent 1214
Device remains implanted 1111
Haptic(s), broken 1044
No code available 996
No Information 849
Other (for use when an appropriate device code cannot be identified) 819
Explanted 680
Haptic Damaged in Delivery System 651
Malposition of device 586
Lens replacement 539
Break 474
Material opacification 434
Lens Damaged in Delivery System 413
Use of Device Issue 407
Lens Stuck in Delivery System 405
Lens, vaulting 304
Unknown (for use when the device problem is not known) 245
Torn material 237
Failure to deliver 212
Scratched material 206
Bent 177
Sticking 167
Dislodged or dislocated 163
Foreign material present in device 158
Lens, stuck in cartridge 147
Inaccurate delivery 111
Defective item 101
Lens (IOL), scratch, mark on 101
Detachment of device component 97
Haptic, Kinked 91
Crack 90
Lens (IOL), dislocated intraocular 89
Difficult to fold or unfold 84
Plunger Override 81
Device or device component damaged by another device 80
Haptic(s), detached 79
Device operates differently than expected 76
Haptic Stuck in Delivery System 75
Optical decentration 74
Difficult to deploy 72
Failure to fold 70
Lens, malposition of 65
Lens, opacification of 64
Failure to deploy 61
Unintended movement 59
Lens Issue, No Description 56
Lens, repositioning of 50
Lens, cloudy 49
Foreign material 49
Fracture 49
Lens, deposits on 48
Failure to unfold or unwrap 47
Implant, removal of 47
Device Issue 41
Positioning Issue 40
Haptic, Stuck to Optic 34
Dissatisfaction 34
Haptic Issue, No Description 33
Mechanical jam 33
Deployment issue 31
Lens, damaged by cartridge 31
Difficult to position 28
Haptic, Missing 28
Size incorrect for patient 27
Failure to advance 26
Difficult to insert 26
Inadequate instructions for healthcare professional 25
Material discolored 25
Calcified 21
Device handling issue 21
Premature deployment 19
Component missing 19
Lens, difficulty loading into cartridge 18
Lens (IOL), defective, problem not specified 16
Haptic(s), fractured 16
Material Distortion 16
Kinked 15
Power calculation error due to software problem 15
Implant, repositioning of 15
Fitting problem 15
Tears, rips, holes in device, device material 14
Physical resistance 14
Material twisted 13
Difficult to advance 13
Patient-device incompatibility 13
Device markings issue 12
Lens (IOL), line, crease on 11
Defective component 11
Loss of or failure to bond 11
Lens, discoloration of 10
Incorrect measurement 10
Bubble(s) 10
Material rigid or stiff 10
Unfold, difficult to 10
Split 10
Blockage within device or device component 9
Total Device Problems 26466

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 2 0
Class II 0 0 1 2 3 0 3 3 3 0
Class III 0 0 0 0 0 1 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 Alcon Research, Ltd. I Nov-25-2015
9 Alcon Research, Ltd. I Aug-07-2015
10 Bausch & Lomb Inc II Jan-11-2010
11 Bausch & Lomb Inc II Sep-09-2009
12 Bausch & Lomb Surgical, Inc. II Jul-20-2015
13 Bausch & Lomb Surgical, Inc. II Feb-20-2014
14 Hoya Surgical Optics, Inc. II Jul-14-2011
15 Medicel Ag II Aug-20-2013
16 Staar Surgical Co. II Jul-17-2013
17 Staar Surgical Co. II Jun-29-2011
18 Tekia, Inc. II Nov-06-2015

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