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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 Approvals (PMA)
2016 2017 2018 2019 2020 2021
48 41 39 57 49 41

MDR Year MDR Reports MDR Events
2016 2213 2213
2017 2386 2386
2018 2499 2499
2019 3086 3603
2020 1982 3097
2021 1957 2128

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3355 3355
Break 2117 3553
Scratched Material 787 851
Crack 548 690
Appropriate Term/Code Not Available 532 532
Device Contamination with Chemical or Other Material 524 524
Device Operates Differently Than Expected 470 470
Unintended Movement 417 417
Insufficient Information 387 387
Material Opacification 385 385
Torn Material 259 259
Contamination 258 258
Failure to Eject 252 252
Device Dislodged or Dislocated 251 251
Defective Device 249 249
Material Split, Cut or Torn 236 236
No Apparent Adverse Event 214 214
Sticking 199 199
Difficult or Delayed Positioning 195 195
Failure to Unfold or Unwrap 188 188
Inadequacy of Device Shape and/or Size 187 187
Positioning Failure 177 177
Contamination /Decontamination Problem 162 162
Material Twisted/Bent 153 153
Material Deformation 150 150
Physical Resistance/Sticking 147 147
Difficult to Fold, Unfold or Collapse 139 139
Defective Component 128 243
Inaccurate Delivery 127 127
Mechanical Jam 120 120
Bent 111 111
Positioning Problem 99 99
Material Fragmentation 94 94
Failure to Advance 93 93
Patient-Device Incompatibility 88 88
Material Integrity Problem 87 87
Device Handling Problem 85 85
Premature Activation 82 82
Detachment Of Device Component 82 82
Malposition of Device 80 80
Difficult to Advance 69 69
Failure to Fold 69 69
Activation, Positioning or SeparationProblem 68 68
Calcified 67 67
Separation Problem 67 67
Entrapment of Device 66 66
Use of Device Problem 65 65
Product Quality Problem 63 63
Improper or Incorrect Procedure or Method 61 61
Split 60 60
Device Contaminated During Manufacture or Shipping 58 58
Material Discolored 54 54
Fracture 53 53
Detachment of Device or Device Component 51 51
Device Damaged by Another Device 51 97
Mechanical Problem 46 46
Optical Problem 46 46
Difficult to Insert 43 43
Unexpected Therapeutic Results 43 43
Material Too Rigid or Stiff 42 42
Unstable 41 41
Material Rupture 33 33
Device Damaged Prior to Use 31 31
Migration or Expulsion of Device 31 31
Ejection Problem 29 29
Packaging Problem 25 25
Deformation Due to Compressive Stress 22 22
Structural Problem 22 22
Optical Distortion 22 22
Delivered as Unsterile Product 22 22
Device Markings/Labelling Problem 21 21
Dent in Material 21 21
Therapeutic or Diagnostic Output Failure 20 43
Kinked 19 19
Material Distortion 18 18
Operating System Becomes Nonfunctional 17 17
Difficult To Position 16 16
Material Separation 15 15
Component Missing 15 15
Failure to Deliver 15 15
Device Difficult to Setup or Prepare 14 14
Manufacturing, Packaging or Shipping Problem 14 14
Device Appears to Trigger Rejection 14 14
Leak/Splash 13 13
Material Protrusion/Extrusion 13 13
Inaccurate Information 12 12
Hole In Material 12 12
Folded 12 12
Device Slipped 11 11
Optical Discoloration 11 11
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 11 11
Sharp Edges 11 11
Contamination of Device Ingredient or Reagent 10 10
Patient Device Interaction Problem 10 10
Wrinkled 10 10
Failure to Align 10 10
Cut In Material 9 9
Incorrect, Inadequate or Imprecise Resultor Readings 9 9
Off-Label Use 9 9
Particulates 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 3456 3456
No Known Impact Or Consequence To Patient 2652 2837
No Consequences Or Impact To Patient 2161 3733
No Clinical Signs, Symptoms or Conditions 1292 1322
No Patient Involvement 1004 1004
Visual Impairment 970 970
Capsular Bag Tear 827 827
Vitrectomy 670 670
Blurred Vision 657 658
Visual Disturbances 551 551
Inflammation 249 249
No Information 248 248
Insufficient Information 204 237
Corneal Edema 176 176
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 170 170
Halo 165 165
Failure of Implant 147 147
Endophthalmitis 142 142
Eye Injury 117 117
Pain 100 100
Intraocular Pressure Increased 92 92
Loss of Vision 85 85
Therapeutic Effects, Unexpected 72 72
Discomfort 64 64
Rupture 55 55
Vitreous Loss 53 53
Unspecified Infection 51 51
Hemorrhage/Bleeding 48 48
Dry Eye(s) 47 47
Macular Edema 43 43
Foreign Body In Patient 43 43
Edema 39 39
Red Eye(s) 33 33
Uveitis 30 30
Zonular Dehiscence 30 30
Toxic Anterior Segment Syndrome (TASS) 30 30
Vitreous Floaters 26 26
Glaucoma 26 26
Hypopyon 25 25
Iritis 24 24
Complaint, Ill-Defined 23 23
Tissue Damage 22 22
Hyphema 22 22
Foreign Body Sensation in Eye 22 22
Irritation 21 21
Corneal Clouding/Hazing 20 20
Retinal Detachment 20 20
Reaction 19 19
Patient Problem/Medical Problem 18 18
Headache 18 18
Swelling 18 19
Injury 17 17
Flashers 16 16
Deposits 14 14
Dizziness 14 14
Capsular Contracture 14 14
Foreign Body Reaction 13 13
Nausea 13 13
Fibrosis 13 13
Burning Sensation 13 13
Calcium Deposits/Calcification 12 12
Erythema 11 11
Discharge 11 11
Excessive Tear Production 11 11
Therapeutic Response, Decreased 11 11
Eye Pain 11 11
Prolapse 10 10
Increased Sensitivity 10 10
UGH (Uveitis-Glaucoma-Hyphema) Syndrome 9 9
Toxicity 9 9
Bacterial Infection 9 9
Hyperemia 8 8
Retinal Tear 8 8
Corneal Abrasion 8 8
Device Embedded In Tissue or Plaque 7 7
Vitreous Detachment 7 7
Disability 7 7
Itching Sensation 6 6
Corneal Decompensation 6 6
Cataract 6 6
High Blood Pressure/ Hypertension 6 6
Vitreous Hemorrhage 6 6
Vitritis 6 6
Intraocular Infection 5 5
Scarring 5 5
Laceration(s) 4 4
Adhesion(s) 4 4
Clouding, Central Corneal 4 4
Blood Loss 4 4
Not Applicable 4 4
Swelling/ Edema 4 4
Conjunctivitis 4 4
Fungal Infection 4 4
Unspecified Eye / Vision Problem 4 4
Eye Infections 3 3
Increased Sensitivity 3 3
Collapse 3 3
Chemosis 3 3
Wound Dehiscence 3 3
Rash 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical Optics Inc. (AMO) II Sep-21-2016
2 Alcon Research LLC II Jun-05-2020
3 Alcon Research, Ltd. II Sep-01-2016
4 Bausch & Lomb Surgical, Inc. II Jul-10-2020
5 Bausch & Lomb Surgical, Inc. II Dec-18-2018
6 Johnson & Johnson Surgical Vision Inc II Nov-14-2018
7 Rayner Intraocular Lenses Limited II Sep-28-2018
8 Tekia, Inc. II Dec-17-2019
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