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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 20

MDR Year MDR Reports MDR Events
2017 2386 2386
2018 2499 2499
2019 3086 3603
2020 1982 3097
2021 2929 3100
2022 1971 1971

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3498 3498
Break 2660 4096
Scratched Material 985 1049
Crack 638 780
Device Contamination with Chemical or Other Material 473 473
Appropriate Term/Code Not Available 461 461
Material Opacification 369 369
Device Operates Differently Than Expected 359 359
Defective Device 352 352
Unintended Movement 350 350
Material Split, Cut or Torn 344 344
Contamination 332 332
Failure to Eject 331 331
Device Dislodged or Dislocated 309 309
Inaccurate Delivery 265 265
Insufficient Information 246 246
No Apparent Adverse Event 217 217
Material Fragmentation 206 206
Failure to Unfold or Unwrap 183 183
Failure to Advance 182 182
Mechanical Jam 179 179
Difficult to Fold, Unfold or Collapse 167 167
Inadequacy of Device Shape and/or Size 165 165
Material Twisted/Bent 165 165
Contamination /Decontamination Problem 163 163
Physical Resistance/Sticking 162 162
Defective Component 139 254
Material Deformation 138 138
Positioning Failure 118 118
Sticking 117 117
Difficult or Delayed Positioning 115 115
Torn Material 102 102
Failure to Fold 100 100
Use of Device Problem 91 91
Positioning Problem 89 89
Device Damaged by Another Device 85 131
Difficult to Advance 85 85
Patient-Device Incompatibility 85 85
Device Contaminated During Manufacture or Shipping 80 80
Malposition of Device 78 78
Material Integrity Problem 75 75
Bent 74 74
Device Handling Problem 72 72
Mechanical Problem 71 71
Premature Activation 68 68
Separation Problem 67 67
Product Quality Problem 64 64
Calcified 64 64
Improper or Incorrect Procedure or Method 62 62
Material Discolored 57 57
Difficult to Insert 55 55
Material Too Rigid or Stiff 54 54
Detachment Of Device Component 53 53
Detachment of Device or Device Component 50 50
Split 46 46
Unstable 46 46
Activation, Positioning or SeparationProblem 45 45
Device Difficult to Setup or Prepare 45 45
Optical Problem 44 44
Operating System Becomes Nonfunctional 42 42
Unexpected Therapeutic Results 41 41
Fracture 41 41
Entrapment of Device 41 41
Ejection Problem 39 39
Delivered as Unsterile Product 37 37
Device Markings/Labelling Problem 36 36
Device Damaged Prior to Use 32 32
Manufacturing, Packaging or Shipping Problem 31 31
Material Rupture 28 28
Migration or Expulsion of Device 26 26
Device Appears to Trigger Rejection 25 25
Off-Label Use 25 25
Optical Distortion 22 22
Sharp Edges 22 22
Deformation Due to Compressive Stress 21 21
Unintended Ejection 21 21
Structural Problem 20 20
Therapeutic or Diagnostic Output Failure 20 43
Failure to Align 19 19
Dent in Material 18 18
Material Separation 15 15
Failure to Deliver 14 14
Component Missing 13 13
Incorrect, Inadequate or Imprecise Resultor 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 2852 2882
No Code Available 2811 2811
No Known Impact Or Consequence To Patient 2248 2433
No Consequences Or Impact To Patient 1706 3278
Visual Impairment 1058 1058
Capsular Bag Tear 848 848
No Patient Involvement 843 843
Blurred Vision 788 789
Visual Disturbances 673 673
Vitrectomy 560 560
Insufficient Information 505 538
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 383 383
Halo 245 245
Failure of Implant 215 215
Inflammation 213 213
Corneal Edema 185 185
No Information 185 185
Eye Injury 184 184
Endophthalmitis 146 146
Intraocular Pressure Increased 95 95
Pain 80 80
Discomfort 75 75
Therapeutic Effects, Unexpected 69 69
Loss of Vision 65 65
Dry Eye(s) 52 52
Vitreous Loss 50 50
Toxic Anterior Segment Syndrome (TASS) 49 49
Uveitis 47 47
Unspecified Infection 44 44
Hemorrhage/Bleeding 43 43
Macular Edema 43 43
Rupture 43 43
Foreign Body In Patient 38 38
Eye Pain 36 36
Vitreous Floaters 35 35
Edema 34 34
Red Eye(s) 33 33
Zonular Dehiscence 32 32
Iritis 30 30
Flashers 30 30
Retinal Detachment 28 28
Glaucoma 26 26
Hypopyon 25 25
Foreign Body Sensation in Eye 25 25
Corneal Clouding/Hazing 24 24
Hyphema 23 23
Irritation 19 19
Fibrosis 16 16
Patient Problem/Medical Problem 16 16
Swelling 15 16
Tissue Damage 14 14
Vitreous Hemorrhage 13 13
Complaint, Ill-Defined 13 13
Reaction 13 13
Deposits 13 13
Headache 12 12
Dizziness 12 12
Excessive Tear Production 12 12
Nausea 11 11
Calcium Deposits/Calcification 11 11
Capsular Contracture 11 11
Erythema 10 10
Retinal Tear 10 10
Injury 10 10
Burning Sensation 10 10
Prolapse 10 10
Vitreous Detachment 9 9
UGH (Uveitis-Glaucoma-Hyphema) Syndrome 9 9
Discharge 9 9
Bacterial Infection 9 9
Increased Sensitivity 8 8
Hyperemia 8 8
Therapeutic Response, Decreased 8 8
Corneal Decompensation 7 7
Swelling/ Edema 7 7
Conjunctivitis 6 6
Corneal Abrasion 6 6
High Blood Pressure/ Hypertension 6 6
Intraocular Infection 6 6
Intraocular Pressure Decreased 6 6
Eye Infections 6 6
Unspecified Eye / Vision Problem 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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