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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lens, multifocal intraocular
Product CodeMFK
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
12 8 4 8 8 3

MDR Year MDR Reports MDR Events
2018 628 628
2019 683 696
2020 912 919
2021 1205 1205
2022 1265 1265
2023 720 720

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3236 3236
Scratched Material 338 338
Appropriate Term/Code Not Available 324 324
Break 193 213
Patient-Device Incompatibility 167 167
Device Dislodged or Dislocated 156 156
Defective Device 142 142
Crack 113 113
Material Opacification 92 92
Malposition of Device 77 77
Device Contamination with Chemical or Other Material 72 72
Insufficient Information 68 68
Therapeutic or Diagnostic Output Failure 50 50
Material Split, Cut or Torn 43 43
Mechanical Problem 37 37
Unexpected Therapeutic Results 34 34
Unintended Movement 31 31
Defective Component 29 29
Inadequacy of Device Shape and/or Size 28 28
Device Operates Differently Than Expected 24 24
Failure to Advance 23 23
Contamination /Decontamination Problem 21 21
Positioning Problem 20 20
Mechanical Jam 14 14
Material Discolored 14 14
Device Difficult to Setup or Prepare 13 13
Material Deformation 13 13
Power Problem 13 13
Device Damaged by Another Device 12 12
Contamination 11 11
Inaccurate Delivery 11 11
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Improper or Incorrect Procedure or Method 11 11
Failure to Unfold or Unwrap 10 10
Application Program Problem: Power Calculation Error 10 10
Migration or Expulsion of Device 9 9
Difficult to Fold, Unfold or Collapse 9 9
Material Fragmentation 9 9
Product Quality Problem 9 9
Device Markings/Labelling Problem 9 9
Failure to Eject 9 9
Operating System Becomes Nonfunctional 8 8
Unstable 8 8
Application Program Problem: Dose Calculation Error 7 7
Positioning Failure 6 6
Optical Decentration 6 6
Use of Device Problem 6 6
Structural Problem 6 6
Failure to Align 6 6
Difficult to Advance 6 6
Physical Resistance/Sticking 6 6
Material Integrity Problem 5 5
Activation, Positioning or Separation Problem 5 5
Material Too Rigid or Stiff 5 5
Particulates 5 5
Bent 5 5
Difficult to Insert 4 4
Device Displays Incorrect Message 4 4
Detachment of Device or Device Component 3 3
Device Damaged Prior to Use 3 3
Material Rupture 3 3
Delivered as Unsterile Product 3 3
Labelling, Instructions for Use or Training Problem 3 3
Incorrect Measurement 3 3
Entrapment of Device 3 3
Material Frayed 3 3
Failure to Fold 3 3
Fracture 3 3
Material Twisted/Bent 3 3
Optical Problem 3 3
Output Problem 3 3
Patient Device Interaction Problem 3 3
Separation Problem 3 3
Ejection Problem 2 2
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Optical Distortion 2 2
Calcified 2 2
Fogging 2 2
Loose or Intermittent Connection 2 2
Suction Problem 2 2
Unable to Obtain Readings 2 2
Device Slipped 2 2
Sticking 2 2
Component Missing 2 2
Invalid Sensing 2 2
Dent in Material 2 2
Microbial Contamination of Device 1 1
Deformation Due to Compressive Stress 1 1
Stretched 1 1
Difficult to Remove 1 1
Fitting Problem 1 1
Device Inoperable 1 1
Leak/Splash 1 1
Misassembled 1 1
Misfocusing 1 1
Poor Quality Image 1 1
Loss of Power 1 1
Material Puncture/Hole 1 1
Biofilm coating in Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blurred Vision 1521 1521
Visual Disturbances 1365 1365
Visual Impairment 1252 1252
Halo 1058 1058
No Code Available 703 703
No Clinical Signs, Symptoms or Conditions 432 432
Insufficient Information 368 368
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 318 318
No Known Impact Or Consequence To Patient 202 202
Inflammation 129 129
Dry Eye(s) 126 126
Discomfort 105 105
Failure of Implant 93 93
Pain 80 80
Headache 77 77
No Consequences Or Impact To Patient 72 92
Eye Pain 59 59
Eye Injury 58 58
Corneal Edema 53 53
Capsular Bag Tear 51 51
Loss of Vision 50 50
Therapeutic Effects, Unexpected 50 50
Endophthalmitis 48 48
Vitreous Floaters 47 47
Vitrectomy 43 43
Flashers 40 40
Uveitis 40 40
Red Eye(s) 32 32
Foreign Body Sensation in Eye 31 31
Intraocular Pressure Increased 27 27
Macular Edema 26 26
Unspecified Infection 24 24
Unspecified Eye / Vision Problem 23 23
No Patient Involvement 18 18
Dizziness 16 16
Swelling 14 14
No Information 13 13
Iritis 11 11
Nausea 11 11
Hypopyon 11 11
Excessive Tear Production 10 10
Therapeutic Response, Decreased 10 10
Inadequate Pain Relief 10 10
Toxic Anterior Segment Syndrome (TASS) 9 9
Swelling/ Edema 9 9
Conjunctivitis 9 9
Increased Sensitivity 9 9
Corneal Clouding/Hazing 8 8
Patient Problem/Medical Problem 8 8
Zonular Dehiscence 8 8
Complaint, Ill-Defined 8 8
Burning Sensation 7 7
Foreign Body In Patient 7 7
Reaction 7 7
Irritability 7 7
Fatigue 7 7
Hyperemia 7 7
Corneal Scar 7 7
Vertigo 7 7
Keratitis 7 7
Retinal Detachment 6 6
Emotional Changes 6 6
Hemorrhage/Bleeding 6 6
Fibrosis 6 6
Toxicity 6 6
Injury 5 5
Depression 5 5
Anxiety 5 5
Vitreous Detachment 5 5
Edema 5 5
Cataract 5 5
Hyphema 5 5
Vitreous Loss 5 5
Scar Tissue 5 5
Retinal Tear 4 4
Itching Sensation 4 4
Corneal Abrasion 4 4
Erythema 4 4
Hypersensitivity/Allergic reaction 4 4
Decreased Sensitivity 4 4
Clouding, Central Corneal 4 4
Increased Sensitivity 4 4
Prolapse 3 3
Fall 3 3
Capsular Contracture 3 3
Purulent Discharge 3 3
Cataract, Induced 3 3
Scarring 3 3
Vitreous Hemorrhage 3 3
Toxic Shock Syndrome 3 3
Staphylococcus Aureus 2 2
Tissue Damage 2 2
Irritation 2 2
Retinal Degeneration 2 2
Nerve Damage 2 2
Confusion/ Disorientation 2 2
Impaired Healing 2 2
Twitching 2 2
Vitritis 2 2
Distress 2 2

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