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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 95 95

Device Problems MDRs with this Device Problem Events in those MDRs
Break 257 274
Device Damaged by Another Device 255 289
Failure to Eject 245 245
Crack 196 302
Scratched Material 168 168
Defective Device 139 139
Contamination 121 121
Failure to Advance 102 102
Physical Resistance/Sticking 96 96
Defective Component 68 68
Material Twisted/Bent 65 65
Activation, Positioning or Separation Problem 64 64
Material Split, Cut or Torn 59 59
Adverse Event Without Identified Device or Use Problem 50 50
Mechanical Jam 45 45
Inaccurate Delivery 45 45
Appropriate Term/Code Not Available 43 43
Difficult to Advance 41 41
Device Contamination with Chemical or Other Material 40 40
Unintended Ejection 40 40
Failure to Unfold or Unwrap 34 34
Positioning Problem 29 29
Mechanical Problem 25 25
Material Deformation 24 24
Failure to Deliver 21 21
Material Fragmentation 19 19
Therapeutic or Diagnostic Output Failure 19 19
Entrapment of Device 18 18
Device Difficult to Setup or Prepare 16 16
Material Integrity Problem 15 15
Malposition of Device 14 14
Failure to Fold 13 13
Contamination /Decontamination Problem 13 13
Device Dislodged or Dislocated 12 12
Difficult to Fold, Unfold or Collapse 12 12
Difficult to Insert 11 11
Premature Activation 10 10
Delivered as Unsterile Product 9 9
Use of Device Problem 9 9
Unintended Movement 9 9
Manufacturing, Packaging or Shipping Problem 8 8
Detachment of Device or Device Component 8 8
Material Too Rigid or Stiff 7 7
Positioning Failure 6 6
Deformation Due to Compressive Stress 6 6
Failure to Align 5 5
Misfire 5 5
Material Opacification 5 5
Device Contaminated During Manufacture or Shipping 5 5
Ejection Problem 5 5
Firing Problem 5 5
Output Problem 4 4
Device Markings/Labelling Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Device Damaged Prior to Use 4 4
Material Separation 4 4
Component Missing 4 4
Device Slipped 3 3
Stretched 3 3
Material Discolored 3 3
Activation Problem 3 3
No Apparent Adverse Event 3 3
Insufficient Information 2 2
Pressure Problem 2 2
Sharp Edges 2 2
Mechanics Altered 2 2
Difficult to Open or Close 2 2
Output above Specifications 2 2
Migration or Expulsion of Device 2 2
Material Rupture 2 2
Product Quality Problem 2 2
Difficult to Remove 2 2
Loose or Intermittent Connection 2 2
Particulates 2 2
Structural Problem 2 2
Device Displays Incorrect Message 2 2
Failure to Fire 1 1
Device Tipped Over 1 1
Separation Failure 1 1
Dent in Material 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Patient-Device Incompatibility 1 1
Failure to Infuse 1 1
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1
Unstable 1 1
Inadequacy of Device Shape and/or Size 1 1
Peeled/Delaminated 1 1
Self-Activation or Keying 1 1
Misassembled 1 1
Material Frayed 1 1
Image Orientation Incorrect 1 1
Unsealed Device Packaging 1 1
Unintended Collision 1 1
Material Disintegration 1 1
Difficult or Delayed Positioning 1 1
Corroded 1 1
Complete Blockage 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Invagination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 675 685
No Known Impact Or Consequence To Patient 527 548
Insufficient Information 329 342
No Consequences Or Impact To Patient 252 365
Capsular Bag Tear 58 58
No Code Available 44 44
No Patient Involvement 41 41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Failure of Implant 28 28
Corneal Edema 23 23
Eye Injury 22 22
Blurred Vision 14 14
Visual Disturbances 12 12
Eye Pain 11 11
Rupture 10 11
Inflammation 10 10
Visual Impairment 9 9
Tissue Damage 9 9
Endophthalmitis 8 8
Foreign Body In Patient 8 8
Discomfort 5 5
No Information 5 5
Hemorrhage/Bleeding 5 5
Intraocular Pressure Increased 5 5
Uveitis 4 4
Fibrosis 4 4
Prolapse 4 4
Zonular Dehiscence 3 3
Device Embedded In Tissue or Plaque 3 3
Hypopyon 3 3
Unspecified Infection 3 3
Hyperemia 2 2
Hyphema 2 2
Conjunctivitis 2 2
Vitreous Floaters 2 2
Patient Problem/Medical Problem 2 2
Injury 2 2
Blood Loss 2 2
Toxic Anterior Segment Syndrome (TASS) 1 1
Swelling/ Edema 1 1
Collapse 1 1
Vitreous Detachment 1 1
Organ Dehiscence 1 1
Vitreous Hemorrhage 1 1
Vomiting 1 1
Intraoperative Pain 1 1
Vitrectomy 1 1
Glaucoma 1 1
Corneal Clouding/Hazing 1 1
Headache 1 1
Corneal Perforation 1 1
Dry Eye(s) 1 1
Macular Edema 1 1
Corneal Abrasion 1 1
Loss of Vision 1 1
Halo 1 1
Viral Infection 1 1
Nausea 1 1
Pain 1 1
Red Eye(s) 1 1
Retinal Detachment 1 1
Retinal Tear 1 1
Scar Tissue 1 1
Swelling 1 1
Therapeutic Effects, Unexpected 1 1

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