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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 24

Device Problems
No Known Device Problem 4219
Lens (IOL), torn, split, cracked 2331
Packaging issue 2256
Leak 2219
Haptic(s), bent 1214
Device remains implanted 1111
Haptic(s), broken 1044
No code available 1006
No Information 851
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 478
Material opacification 440
Lens Damaged in Delivery System 413
Use of Device Issue 411
Lens Stuck in Delivery System 405
Lens, vaulting 304
Torn material 256
Unknown (for use when the device problem is not known) 245
Failure to deliver 213
Scratched material 212
Foreign material present in device 179
Bent 179
Sticking 172
Dislodged or dislocated 167
Lens, stuck in cartridge 147
Inaccurate delivery 111
Defective item 103
Lens (IOL), scratch, mark on 101
Detachment of device component 100
Crack 93
Haptic, Kinked 91
Lens (IOL), dislocated intraocular 89
Difficult to deploy 87
Difficult to fold or unfold 85
Plunger Override 81
Device operates differently than expected 81
Device or device component damaged by another device 81
Haptic(s), detached 79
Haptic Stuck in Delivery System 75
Failure to fold 74
Optical decentration 74
Failure to deploy 70
Unintended movement 67
Lens, malposition of 65
Lens, opacification of 64
Lens Issue, No Description 56
Lens, repositioning of 50
Lens, cloudy 49
Foreign material 49
Fracture 49
Failure to unfold or unwrap 49
Lens, deposits on 48
Implant, removal of 47
Device Issue 41
Positioning Issue 41
Deployment issue 37
Haptic, Stuck to Optic 34
Mechanical jam 34
Dissatisfaction 34
Haptic Issue, No Description 33
Lens, damaged by cartridge 31
Size incorrect for patient 29
Difficult to position 29
Haptic, Missing 28
Difficult to insert 26
Failure to advance 26
Inadequate instructions for healthcare professional 25
Material discolored 25
Calcified 22
Device handling issue 22
Premature deployment 20
Component missing 19
Lens, difficulty loading into cartridge 18
Material Distortion 18
Lens (IOL), defective, problem not specified 16
Kinked 16
Haptic(s), fractured 16
Power calculation error due to software problem 15
Implant, repositioning of 15
Fitting problem 15
Material twisted 15
Difficult to advance 14
Tears, rips, holes in device, device material 14
Physical resistance 14
Patient-device incompatibility 13
Device markings issue 12
Split 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
Blockage within device or device component 9
Total Device Problems 26686

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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