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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intraocular lens
Product CodeHQL
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
33 44 32 38 30 18 27 48 41 39 57 49 53 34 29 6

MDR Year MDR Reports MDR Events
2014 2649 2649
2015 4673 4673
2016 2214 2214
2017 2386 2386
2018 2501 2501
2019 3086 3603
2020 1981 3096
2021 2925 3096
2022 3290 3290
2023 3909 3957
2024 951 951

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6878 6926
Break 4414 5850
Packaging Problem 2296 2296
Leak/Splash 2245 2245
Scratched Material 1817 1881
Appropriate Term/Code Not Available 1264 1264
Crack 1163 1305
Material Split, Cut or Torn 894 894
Material Opacification 811 811
Device Contamination with Chemical or Other Material 805 805
Defective Device 759 759
Device Operates Differently Than Expected 627 627
Insufficient Information 608 608
Failure to Eject 579 579
Torn Material 574 574
Device Dislodged or Dislocated 544 544
Contamination 489 489
Unintended Movement 477 477
Use of Device Problem 422 422
Sticking 419 419
Material Fragmentation 399 399
Inaccurate Delivery 371 371
Difficult to Fold, Unfold or Collapse 367 367
Failure to Advance 359 359
Failure to Unfold or Unwrap 308 308
Malposition of Device 288 288
Mechanical Jam 284 284
Physical Resistance/Sticking 243 243
Device Damaged by Another Device 236 282
Material Twisted/Bent 234 234
Difficult or Delayed Positioning 229 229
No Apparent Adverse Event 226 226
Positioning Failure 221 221
Inadequacy of Device Shape and/or Size 213 213
Defective Component 210 325
Off-Label Use 198 198
Failure to Fold 189 189
Bent 187 187
Material Deformation 179 179
Contamination /Decontamination Problem 165 165
Ejection Problem 158 158
Material Integrity Problem 143 143
Detachment Of Device Component 142 142
Positioning Problem 140 140
Device Handling Problem 119 119
Difficult to Advance 119 119
Mechanical Problem 119 119
Fracture 114 114
Device Difficult to Setup or Prepare 110 110
Patient-Device Incompatibility 109 109
Difficult to Insert 106 106
Device Markings/Labelling Problem 98 98
Premature Activation 94 94
Optical Problem 90 90
Calcified 89 89
Improper or Incorrect Procedure or Method 86 86
Device Contaminated During Manufacture or Shipping 84 84
Activation, Positioning or Separation Problem 81 81
Unintended Ejection 81 81
Difficult To Position 81 81
Migration or Expulsion of Device 80 80
Entrapment of Device 76 76
Material Discolored 76 76
Product Quality Problem 73 73
Manufacturing, Packaging or Shipping Problem 72 72
Delivered as Unsterile Product 70 70
Sharp Edges 68 68
Separation Problem 67 67
Material Too Rigid or Stiff 67 67
Split 66 66
Detachment of Device or Device Component 63 63
Operating System Becomes Nonfunctional 62 62
Unstable 56 56
Device Appears to Trigger Rejection 48 48
Particulates 48 48
Unexpected Therapeutic Results 46 46
Material Rupture 43 43
Device Damaged Prior to Use 41 41
Component Missing 40 40
Nonstandard Device 34 34
Optical Distortion 34 34
Material Distortion 30 30
Kinked 29 29
Optical Decentration 28 28
Failure to Deliver 27 27
Structural Problem 27 27
Dent in Material 26 26
Material Separation 26 26
Inadequate Instructions for Healthcare Professional 26 26
Deformation Due to Compressive Stress 24 24
Therapeutic or Diagnostic Output Failure 24 47
Folded 21 21
Failure to Align 21 21
Incorrect, Inadequate or Imprecise Result or Readings 21 21
Device Misassembled During Manufacturing /Shipping 19 19
Incorrect Device Or Component Shipped 19 19
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 18 18
Device Slipped 15 15
Hole In Material 15 15
Optical Discoloration 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5614 5644
No Code Available 4895 4895
No Known Impact Or Consequence To Patient 3743 3928
No Patient Involvement 3330 3330
No Consequences Or Impact To Patient 2662 4234
Visual Impairment 2163 2164
Insufficient Information 1796 1829
Capsular Bag Tear 1625 1625
Blurred Vision 1579 1580
Visual Disturbances 1485 1485
Vitrectomy 1002 1002
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 726 774
Failure of Implant 600 600
Inflammation 520 520
No Information 493 493
Halo 485 485
Eye Injury 399 399
Corneal Edema 361 361
Endophthalmitis 305 305
Postoperative refraction, unexpected 255 255
Pain 188 188
Intraocular Pressure Increased 186 234
Discomfort 147 147
Loss of Vision 130 130
Dry Eye(s) 109 109
Macular Edema 102 150
Vitreous Loss 94 94
Uveitis 89 137
Rupture 89 89
Toxic Anterior Segment Syndrome (TASS) 88 88
Eye Pain 81 81
Therapeutic Effects, Unexpected 78 78
Hemorrhage/Bleeding 75 75
Zonular Dehiscence 75 75
Vitreous Floaters 73 73
Unspecified Infection 71 71
Red Eye(s) 70 70
Flashers 65 65
Complaint, Ill-Defined 63 63
Retinal Detachment 56 104
Foreign Body In Patient 55 55
Headache 52 52
Foreign Body Sensation in Eye 48 48
Glaucoma 47 47
Hypopyon 47 47
Edema 47 47
Iritis 43 43
Capsular Contracture 42 42
Hyphema 40 40
Fibrosis 39 39
Corneal Clouding/Hazing 37 37
Reaction 35 35
Swelling 32 33
Tissue Damage 28 28
Irritation 26 26
Intraocular Infection 25 25
Nausea 25 25
Excessive Tear Production 25 25
Vitreous Hemorrhage 24 24
Diplopia 23 23
Hyperemia 22 22
Deposits 22 22
Dizziness 21 21
Unspecified Eye / Vision Problem 21 21
Patient Problem/Medical Problem 20 20
Eye Infections 19 19
Injury 18 18
Vitreous Detachment 18 18
Bacterial Infection 18 18
Prolapse 17 17
Burning Sensation 17 17
Swelling/ Edema 16 16
Retinal Tear 15 15
Therapeutic Response, Decreased 15 15
Itching Sensation 14 14
Hypersensitivity/Allergic reaction 13 13
Foreign Body Reaction 13 13
Cataract 13 13
Calcium Deposits/Calcification 13 13
Corneal Decompensation 13 13
Discharge 13 13
Increased Sensitivity 13 13
Corneal Abrasion 12 12
Conjunctivitis 11 11
Erythema 11 11
Keratitis 11 11
Toxicity 11 11
Vitritis 10 10
UGH (Uveitis-Glaucoma-Hyphema) Syndrome 9 9
Clouding, Central Corneal 8 8
Anxiety 8 8
High Blood Pressure/ Hypertension 8 8
UGH (Uveitis Glaucoma Hyphema) Syndrome 8 8
Altered color perception 8 8
Device Embedded In Tissue or Plaque 8 8
Intraocular Pressure Decreased 7 7
Corneal Stromal Edema 7 7
Adhesion(s) 7 55
Wound Dehiscence 7 7
Disability 7 7

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 Laboratories Ireland, Ltd II Jun-17-2022
10 Alcon Research LLC II Jun-05-2020
11 Alcon Research, Ltd. II Sep-01-2016
12 Alcon Research, Ltd. I Nov-25-2015
13 Alcon Research, Ltd. I Aug-07-2015
14 Bausch & Lomb Inc II Jan-11-2010
15 Bausch & Lomb Inc II Sep-09-2009
16 Bausch & Lomb Surgical, Inc. II Jul-10-2020
17 Bausch & Lomb Surgical, Inc. II Dec-18-2018
18 Bausch & Lomb Surgical, Inc. II Jul-20-2015
19 Bausch & Lomb Surgical, Inc. II Feb-20-2014
20 Hoya Surgical Optics, Inc. II Jul-14-2011
21 Johnson & Johnson Surgical Vision Inc II Nov-14-2018
22 Johnson & Johnson Surgical Vision, Inc. II Aug-03-2023
23 Medicel Ag II Aug-20-2013
24 Rayner Intraocular Lenses Limited II Sep-28-2018
25 Rayner Intraocular Lenses Ltd II Jul-06-2022
26 Staar Surgical Co. II Jul-17-2013
27 Staar Surgical Co. II Jun-29-2011
28 Tekia, Inc. II Dec-17-2019
29 Tekia, Inc. II Nov-06-2015
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