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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 2017
51 48 33 44 32 38 30 18 27 49 15

Device Problems
No Known Device Problem 4519
Lens (IOL), torn, split, cracked 2336
Packaging issue 2257
Leak 2220
Haptic(s), bent 1214
Device remains implanted 1112
No code available 1068
Haptic(s), broken 1045
No Information 858
Other (for use when an appropriate device code cannot be identified) 820
Explanted 681
Haptic Damaged in Delivery System 651
Malposition of device 587
Break 566
Lens replacement 539
Material opacification 482
Use of Device Issue 415
Lens Damaged in Delivery System 413
Lens Stuck in Delivery System 405
Torn material 352
Lens, vaulting 304
Scratched material 289
Foreign material present in device 273
Unknown (for use when the device problem is not known) 246
Sticking 237
Failure to deliver 213
Bent 203
Device operates differently than expected 184
Dislodged or dislocated 182
Crack 155
Lens, stuck in cartridge 147
Difficult to deploy 130
Unintended movement 127
Detachment of device component 120
Inaccurate delivery 111
Defective item 107
Failure to deploy 105
Lens (IOL), scratch, mark on 101
Difficult to fold or unfold 98
Haptic, Kinked 91
Lens (IOL), dislocated intraocular 89
Device or device component damaged by another device 88
Plunger Override 81
Haptic(s), detached 79
Optical decentration 75
Failure to fold 75
Haptic Stuck in Delivery System 75
Lens, malposition of 65
Failure to unfold or unwrap 65
Lens, opacification of 64
Mechanical jam 64
Lens Issue, No Description 56
Fracture 53
Size incorrect for patient 53
Lens, repositioning of 50
Lens, cloudy 49
Foreign material 49
Deployment issue 49
Lens, deposits on 48
Implant, removal of 47
Positioning Issue 46
Device Issue 42
Difficult to position 38
Entrapment of device or device component 38
Dissatisfaction 34
Haptic, Stuck to Optic 34
Haptic Issue, No Description 33
Lens, damaged by cartridge 31
Device handling issue 31
Difficult to insert 30
Failure to advance 28
Haptic, Missing 28
Split 26
Premature deployment 26
Inadequate instructions for healthcare professional 25
Material discolored 25
Calcified 25
Kinked 24
Material Distortion 22
Material deformation 20
Component missing 19
Material twisted 18
Lens, difficulty loading into cartridge 18
Delivery system failure 16
Lens (IOL), defective, problem not specified 16
Power calculation error due to software problem 16
Haptic(s), fractured 16
Tears, rips, holes in device, device material 15
Fitting problem 15
Implant, repositioning of 15
Patient-device incompatibility 15
Device markings issue 15
Difficult to advance 14
Sediment, precipitate or deposit in device or device ingredient 14
Physical resistance 14
Wrinkled 13
Lens (IOL), line, crease on 11
Device damaged prior to use 11
Defective component 11
Material rigid or stiff 11
Total Device Problems 28136

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

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