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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lens, guide, intraocular
Product CodeKYB
Regulation Number 886.4300
Device Class 1

MDR Year MDR Reports MDR Events
2019 703 757
2020 335 408
2021 349 369
2022 294 294
2023 304 304
2024 298 299

Device Problems MDRs with this Device Problem Events in those MDRs
Device Damaged by Another Device 311 345
Failure to Eject 297 297
Break 263 280
Crack 211 318
Scratched Material 172 172
Defective Device 161 161
Failure to Advance 125 125
Contamination 122 122
Physical Resistance/Sticking 99 99
Material Twisted/Bent 80 80
Defective Component 75 75
Activation, Positioning or Separation Problem 64 64
Material Split, Cut or Torn 62 62
Adverse Event Without Identified Device or Use Problem 53 53
Inaccurate Delivery 47 47
Mechanical Jam 46 46
Unintended Ejection 44 44
Difficult to Advance 44 44
Appropriate Term/Code Not Available 43 43
Device Contamination with Chemical or Other Material 40 40
Failure to Unfold or Unwrap 36 36
Positioning Problem 29 29
Mechanical Problem 27 27
Failure to Deliver 25 25
Material Deformation 24 24
Failure to Fold 22 22
Material Fragmentation 20 20
Therapeutic or Diagnostic Output Failure 19 19
Entrapment of Device 18 18
Device Difficult to Setup or Prepare 17 17
Material Integrity Problem 15 15
Malposition of Device 14 14
Device Dislodged or Dislocated 14 14
Contamination /Decontamination Problem 13 13
Difficult to Fold, Unfold or Collapse 12 12
Difficult to Insert 11 11
Use of Device Problem 10 10
Premature Activation 10 10
Delivered as Unsterile Product 9 9
Unintended Movement 9 9
Manufacturing, Packaging or Shipping Problem 8 8
Detachment of Device or Device Component 8 8
Ejection Problem 7 8
Material Too Rigid or Stiff 7 7
Positioning Failure 6 6
Misfire 6 6
Deformation Due to Compressive Stress 6 6
Material Opacification 5 5
Firing Problem 5 5
Failure to Align 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 773 783
No Known Impact Or Consequence To Patient 527 548
Insufficient Information 429 442
No Consequences Or Impact To Patient 252 365
Capsular Bag Tear 59 59
No Code Available 44 44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 43
No Patient Involvement 41 41
Failure of Implant 28 28
Corneal Edema 25 25
Eye Injury 25 25
Blurred Vision 17 17
Visual Disturbances 13 13
Eye Pain 11 11
Inflammation 11 11
Rupture 10 11
Visual Impairment 10 10
Tissue Damage 9 9
Endophthalmitis 8 8
Foreign Body In Patient 8 8
Intraocular Pressure Increased 5 5
Hemorrhage/Bleeding 5 5
No Information 5 5
Discomfort 5 5
Uveitis 4 4
Fibrosis 4 4
Prolapse 4 4
Device Embedded In Tissue or Plaque 3 3
Headache 3 3
Vitreous Floaters 3 3
Zonular Dehiscence 3 3
Hypopyon 3 3
Unspecified Infection 3 3
Conjunctivitis 2 2
Injury 2 2
Blood Loss 2 2
Hyphema 2 2
Hyperemia 2 2
Patient Problem/Medical Problem 2 2
Glaucoma 1 1
Retinal Detachment 1 1
Swelling 1 1
Vomiting 1 1
Viral Infection 1 1
Toxic Anterior Segment Syndrome (TASS) 1 1
Pain 1 1
Scar Tissue 1 1
Dry Eye(s) 1 1
Vitreous Hemorrhage 1 1
Collapse 1 1

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