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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 36

Device Problems
No Known Device Problem 4319
Lens (IOL), torn, split, cracked 2331
Packaging issue 2257
Leak 2220
Haptic(s), bent 1214
Device remains implanted 1112
Haptic(s), broken 1044
No code available 1026
No Information 858
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 500
Material opacification 454
Lens Damaged in Delivery System 413
Use of Device Issue 411
Lens Stuck in Delivery System 405
Lens, vaulting 304
Torn material 285
Unknown (for use when the device problem is not known) 245
Scratched material 223
Failure to deliver 213
Foreign material present in device 201
Sticking 189
Bent 185
Dislodged or dislocated 171
Lens, stuck in cartridge 147
Inaccurate delivery 111
Defective item 104
Detachment of device component 103
Crack 103
Lens (IOL), scratch, mark on 101
Difficult to deploy 92
Haptic, Kinked 91
Device operates differently than expected 89
Difficult to fold or unfold 89
Lens (IOL), dislocated intraocular 89
Device or device component damaged by another device 81
Plunger Override 81
Unintended movement 81
Haptic(s), detached 79
Failure to deploy 78
Haptic Stuck in Delivery System 75
Failure to fold 74
Optical decentration 74
Lens, malposition of 65
Lens, opacification of 64
Lens Issue, No Description 56
Failure to unfold or unwrap 53
Lens, repositioning of 50
Lens, cloudy 49
Foreign material 49
Fracture 49
Lens, deposits on 48
Implant, removal of 47
Device Issue 41
Positioning Issue 41
Deployment issue 40
Haptic, Stuck to Optic 34
Mechanical jam 34
Dissatisfaction 34
Haptic Issue, No Description 33
Size incorrect for patient 32
Difficult to position 32
Lens, damaged by cartridge 31
Haptic, Missing 28
Failure to advance 26
Difficult to insert 26
Inadequate instructions for healthcare professional 25
Material discolored 25
Calcified 23
Premature deployment 23
Device handling issue 23
Material Distortion 19
Component missing 19
Lens, difficulty loading into cartridge 18
Kinked 18
Material twisted 17
Haptic(s), fractured 16
Lens (IOL), defective, problem not specified 16
Implant, repositioning of 15
Fitting problem 15
Power calculation error due to software problem 15
Entrapment of device or device component 15
Tears, rips, holes in device, device material 14
Physical resistance 14
Patient-device incompatibility 14
Device markings issue 14
Difficult to advance 14
Sediment, precipitate or deposit in device or device ingredient 13
Split 13
Material deformation 12
Lens (IOL), line, crease on 11
Defective component 11
Material rigid or stiff 11
Loss of or failure to bond 11
Lens, discoloration of 10
Incorrect measurement 10
Total Device Problems 27033

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 1
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. II Sep-01-2016
9 Alcon Research, Ltd. I Nov-25-2015
10 Alcon Research, Ltd. I Aug-07-2015
11 Bausch & Lomb Inc II Jan-11-2010
12 Bausch & Lomb Inc II Sep-09-2009
13 Bausch & Lomb Surgical, Inc. II Jul-20-2015
14 Bausch & Lomb Surgical, Inc. II Feb-20-2014
15 Hoya Surgical Optics, Inc. II Jul-14-2011
16 Medicel Ag II Aug-20-2013
17 Staar Surgical Co. II Jul-17-2013
18 Staar Surgical Co. II Jun-29-2011
19 Tekia, Inc. II Nov-06-2015

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