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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)
2017 2018 2019 2020 2021 2022
41 39 57 49 54 27

MDR Year MDR Reports MDR Events
2017 2386 2386
2018 2499 2499
2019 3086 3603
2020 1982 3097
2021 2929 3100
2022 2701 2701

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3641 3641
Break 2803 4239
Scratched Material 1064 1128
Crack 712 854
Device Contamination with Chemical or Other Material 491 491
Appropriate Term/Code Not Available 477 477
Defective Device 394 394
Material Opacification 390 390
Material Split, Cut or Torn 376 376
Device Operates Differently Than Expected 359 359
Contamination 353 353
Failure to Eject 350 350
Unintended Movement 350 350
Device Dislodged or Dislocated 329 329
Inaccurate Delivery 291 291
Insufficient Information 250 250
Material Fragmentation 234 234
No Apparent Adverse Event 218 218
Failure to Advance 203 203
Mechanical Jam 196 196
Failure to Unfold or Unwrap 191 191
Difficult to Fold, Unfold or Collapse 180 180
Material Twisted/Bent 170 170
Physical Resistance/Sticking 167 167
Inadequacy of Device Shape and/or Size 165 165
Contamination /Decontamination Problem 164 164
Defective Component 146 261
Material Deformation 138 138
Positioning Failure 118 118
Sticking 117 117
Difficult or Delayed Positioning 115 115
Failure to Fold 113 113
Use of Device Problem 104 104
Device Damaged by Another Device 104 150
Torn Material 102 102
Difficult to Advance 93 93
Positioning Problem 89 89
Patient-Device Incompatibility 85 85
Malposition of Device 82 82
Device Contaminated During Manufacture or Shipping 82 82
Material Integrity Problem 78 78
Mechanical Problem 78 78
Bent 74 74
Optical Problem 72 72
Device Handling Problem 72 72
Premature Activation 68 68
Separation Problem 67 67
Calcified 66 66
Product Quality Problem 65 65
Improper or Incorrect Procedure or Method 62 62
Difficult to Insert 61 61
Material Discolored 59 59
Device Difficult to Setup or Prepare 55 55
Material Too Rigid or Stiff 54 54
Detachment Of Device Component 53 53
Detachment of Device or Device Component 51 51
Split 46 46
Unstable 46 46
Activation, Positioning or Separation Problem 45 45
Operating System Becomes Nonfunctional 44 44
Delivered as Unsterile Product 43 43
Fracture 42 42
Ejection Problem 42 42
Entrapment of Device 41 41
Unexpected Therapeutic Results 41 41
Device Markings/Labelling Problem 37 37
Off-Label Use 34 34
Device Damaged Prior to Use 32 32
Manufacturing, Packaging or Shipping Problem 31 31
Material Rupture 28 28
Device Appears to Trigger Rejection 27 27
Migration or Expulsion of Device 26 26
Unintended Ejection 26 26
Optical Distortion 23 23
Sharp Edges 22 22
Deformation Due to Compressive Stress 21 21
Structural Problem 20 20
Therapeutic or Diagnostic Output Failure 20 43
Failure to Align 19 19
Dent in Material 18 18
Failure to Deliver 15 15
Material Separation 15 15
Component Missing 14 14
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Hole In Material 12 12
Folded 12 12
Packaging Problem 12 12
Inaccurate Information 12 12
Patient Device Interaction Problem 10 10
Material Protrusion/Extrusion 10 10
Contamination of Device Ingredient or Reagent 10 10
Kinked 10 10
Particulates 10 10
Optical Decentration 9 9
Material Frayed 9 9
Difficult To Position 8 8
Misfocusing 8 8
Device Slipped 8 8
Output Problem 8 8
Material Distortion 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3181 3211
No Code Available 2811 2811
No Known Impact Or Consequence To Patient 2248 2433
No Consequences Or Impact To Patient 1706 3278
Visual Impairment 1129 1129
Capsular Bag Tear 878 878
No Patient Involvement 843 843
Blurred Vision 833 834
Visual Disturbances 722 722
Insufficient Information 646 679
Vitrectomy 560 560
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 450 450
Halo 258 258
Failure of Implant 228 228
Inflammation 216 216
Eye Injury 205 205
Corneal Edema 193 193
No Information 185 185
Endophthalmitis 154 154
Intraocular Pressure Increased 99 99
Discomfort 81 81
Pain 80 80
Therapeutic Effects, Unexpected 69 69
Loss of Vision 65 65
Dry Eye(s) 55 55
Uveitis 53 53
Toxic Anterior Segment Syndrome (TASS) 53 53
Vitreous Loss 51 51
Macular Edema 50 50
Unspecified Infection 44 44
Eye Pain 44 44
Rupture 43 43
Hemorrhage/Bleeding 43 43
Zonular Dehiscence 40 40
Red Eye(s) 39 39
Foreign Body In Patient 38 38
Vitreous Floaters 36 36
Edema 34 34
Retinal Detachment 32 32
Iritis 31 31
Flashers 31 31
Glaucoma 27 27
Hypopyon 27 27
Foreign Body Sensation in Eye 26 26
Hyphema 25 25
Corneal Clouding/Hazing 24 24
Irritation 19 19
Fibrosis 18 18
Patient Problem/Medical Problem 16 16
Swelling 15 16
Headache 15 15
Tissue Damage 14 14
Vitreous Hemorrhage 13 13
Complaint, Ill-Defined 13 13
Reaction 13 13
Deposits 13 13
Capsular Contracture 12 12
Hyperemia 12 12
Dizziness 12 12
Excessive Tear Production 12 12
Nausea 11 11
Calcium Deposits/Calcification 11 11
Erythema 10 10
Retinal Tear 10 10
Injury 10 10
Burning Sensation 10 10
Vitreous Detachment 10 10
Prolapse 10 10
UGH (Uveitis-Glaucoma-Hyphema) Syndrome 9 9
Discharge 9 9
Bacterial Infection 9 9
Increased Sensitivity 8 8
Therapeutic Response, Decreased 8 8
Corneal Abrasion 7 7
Corneal Decompensation 7 7
Swelling/ Edema 7 7
Unspecified Eye / Vision Problem 7 7
Conjunctivitis 6 6
Intraocular Infection 6 6
High Blood Pressure/ Hypertension 6 6
Intraocular Pressure Decreased 6 6
Eye Infections 6 6
Impaired Healing 5 5
Scarring 5 5
Cataract 5 5
Wound Dehiscence 4 4
Adhesion(s) 4 4
Itching Sensation 4 4
Keratitis 4 4
Laceration(s) 4 4
Anxiety 4 4
Inadequate Pain Relief 4 4
Disability 4 4
Blood Loss 4 4
Collapse 3 3
UGH (Uveitis Glaucoma Hyphema) Syndrome 3 3
Device Embedded In Tissue or Plaque 3 3
Clouding, Central Corneal 3 3
Toxicity 3 3
Vitritis 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Laboratories Ireland, Ltd II Jun-17-2022
2 Alcon Research LLC II Jun-05-2020
3 Bausch & Lomb Surgical, Inc. II Jul-10-2020
4 Bausch & Lomb Surgical, Inc. II Dec-18-2018
5 Johnson & Johnson Surgical Vision Inc II Nov-14-2018
6 Rayner Intraocular Lenses Limited II Sep-28-2018
7 Rayner Intraocular Lenses Ltd II Jul-06-2022
8 Tekia, Inc. II Dec-17-2019
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