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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)
2019 2020 2021 2022 2023 2024
8 4 8 8 6 6

MDR Year MDR Reports MDR Events
2019 683 696
2020 912 919
2021 1205 1205
2022 1265 1265
2023 1048 1048
2024 634 678

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3553 3576
Scratched Material 385 386
Appropriate Term/Code Not Available 314 314
Break 244 264
Device Dislodged or Dislocated 181 181
Defective Device 170 170
Patient-Device Incompatibility 143 143
Crack 132 132
Material Opacification 87 87
Malposition of Device 86 86
Device Contamination with Chemical or Other Material 71 71
Therapeutic or Diagnostic Output Failure 50 50
Material Split, Cut or Torn 47 47
Mechanical Problem 35 35
Defective Component 32 32
Failure to Eject 27 27
Unexpected Therapeutic Results 26 26
Failure to Advance 26 26
Device Difficult to Setup or Prepare 25 25
Unintended Movement 25 25
Insufficient Information 22 22
Material Deformation 21 21
Mechanical Jam 19 19
Contamination /Decontamination Problem 19 19
Device Damaged by Another Device 18 18
Positioning Problem 16 16
Material Discolored 15 15
Contamination 14 14
Material Fragmentation 13 13
Unstable 12 12
Power Problem 12 12
Ejection Problem 11 11
Difficult to Fold, Unfold or Collapse 11 11
Application Program Problem: Power Calculation Error 11 11
Device Markings/Labelling Problem 10 10
Failure to Unfold or Unwrap 10 10
Inaccurate Delivery 10 10
Optical Decentration 10 10
Application Program Problem: Dose Calculation Error 9 9
Operating System Becomes Nonfunctional 9 9
Improper or Incorrect Procedure or Method 9 9
Product Quality Problem 8 8
Failure to Align 8 8
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Particulates 7 7
Positioning Failure 6 6
Material Too Rigid or Stiff 6 6
Material Twisted/Bent 6 6
Structural Problem 6 6
Physical Resistance/Sticking 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blurred Vision 1765 1774
Visual Disturbances 1586 1592
Visual Impairment 1351 1353
Halo 1119 1123
No Clinical Signs, Symptoms or Conditions 563 568
Insufficient Information 500 500
No Code Available 438 438
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 355 355
No Known Impact Or Consequence To Patient 176 176
Dry Eye(s) 131 131
Discomfort 118 118
Failure of Implant 87 87
Headache 81 81
Eye Injury 81 81
Inflammation 78 78
Eye Pain 76 78
Corneal Edema 62 62
Capsular Bag Tear 62 62
No Consequences Or Impact To Patient 61 81
Vitreous Floaters 61 61
Flashers 52 53
Pain 50 50
Therapeutic Effects, Unexpected 46 46
Intraocular Pressure Increased 34 34
Loss of Vision 30 30
Endophthalmitis 30 30
Foreign Body Sensation in Eye 29 29
Red Eye(s) 26 26
Vitrectomy 25 25
Macular Edema 24 24
Unspecified Eye / Vision Problem 23 23
Uveitis 20 20
Dizziness 16 16
Unspecified Infection 14 14
Swelling 14 14
No Patient Involvement 11 11
Inadequate Pain Relief 10 10
Swelling/ Edema 10 10
Fibrosis 9 9
Toxic Anterior Segment Syndrome (TASS) 9 9
Therapeutic Response, Decreased 9 9
Corneal Clouding/Hazing 8 8
Excessive Tear Production 8 8
Zonular Dehiscence 8 8
Iritis 8 8
Conjunctivitis 8 8
No Information 8 8
Nausea 8 8
Increased Sensitivity 7 7
Retinal Tear 7 7

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