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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 8

Device Problems
No Known Device Problem 4114
Lens (IOL), torn, split, cracked 2331
Packaging issue 2251
Leak 2215
Haptic(s), bent 1214
Device remains implanted 1111
Haptic(s), broken 1044
No code available 987
No Information 846
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 463
Material opacification 427
Lens Damaged in Delivery System 413
Use of Device Issue 405
Lens Stuck in Delivery System 405
Lens, vaulting 304
Unknown (for use when the device problem is not known) 245
Torn material 222
Failure to deliver 212
Scratched material 203
Bent 170
Dislodged or dislocated 161
Sticking 159
Foreign material present in device 148
Lens, stuck in cartridge 147
Inaccurate delivery 111
Defective item 101
Lens (IOL), scratch, mark on 101
Detachment of device component 95
Haptic, Kinked 91
Lens (IOL), dislocated intraocular 89
Crack 82
Plunger Override 81
Device or device component damaged by another device 80
Haptic(s), detached 79
Difficult to fold or unfold 75
Haptic Stuck in Delivery System 75
Device operates differently than expected 75
Optical decentration 74
Failure to fold 70
Lens, malposition of 65
Lens, opacification of 64
Difficult to deploy 59
Unintended movement 56
Lens Issue, No Description 56
Failure to deploy 56
Lens, repositioning of 50
Foreign material 49
Lens, cloudy 49
Fracture 48
Lens, deposits on 48
Implant, removal of 47
Failure to unfold or unwrap 45
Device Issue 41
Positioning Issue 39
Dissatisfaction 34
Haptic, Stuck to Optic 34
Haptic Issue, No Description 33
Lens, damaged by cartridge 31
Mechanical jam 31
Difficult to position 28
Haptic, Missing 28
Deployment issue 27
Failure to advance 26
Difficult to insert 26
Size incorrect for patient 25
Material discolored 25
Inadequate instructions for healthcare professional 25
Device handling issue 21
Calcified 20
Component missing 19
Lens, difficulty loading into cartridge 18
Premature deployment 18
Haptic(s), fractured 16
Lens (IOL), defective, problem not specified 16
Implant, repositioning of 15
Kinked 15
Power calculation error due to software problem 15
Fitting problem 15
Material Distortion 14
Tears, rips, holes in device, device material 14
Physical resistance 14
Patient-device incompatibility 13
Material twisted 12
Device markings issue 12
Difficult to advance 12
Lens (IOL), line, crease on 11
Defective component 11
Loss of or failure to bond 11
Incorrect measurement 10
Unfold, difficult to 10
Bubble(s) 10
Split 10
Material rigid or stiff 10
Lens, discoloration of 10
Blockage within device or device component 9
Total Device Problems 26277

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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