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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 191 191

Device Problems MDRs with this Device Problem Events in those MDRs
Device Damaged by Another Device 287 321
Failure to Eject 264 264
Break 261 278
Crack 204 310
Scratched Material 171 171
Defective Device 148 148
Contamination 122 122
Failure to Advance 113 113
Physical Resistance/Sticking 98 98
Defective Component 72 72
Material Twisted/Bent 72 72
Activation, Positioning or Separation Problem 64 64
Material Split, Cut or Torn 60 60
Adverse Event Without Identified Device or Use Problem 52 52
Inaccurate Delivery 46 46
Mechanical Jam 45 45
Difficult to Advance 43 43
Appropriate Term/Code Not Available 43 43
Unintended Ejection 42 42
Device Contamination with Chemical or Other Material 40 40
Failure to Unfold or Unwrap 36 36
Positioning Problem 29 29
Mechanical Problem 25 25
Material Deformation 24 24
Failure to Deliver 21 21
Material Fragmentation 20 20
Therapeutic or Diagnostic Output Failure 19 19
Failure to Fold 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
Device Dislodged or Dislocated 13 13
Contamination /Decontamination Problem 13 13
Difficult to Fold, Unfold or Collapse 12 12
Difficult to Insert 11 11
Premature Activation 10 10
Use of Device Problem 10 10
Delivered as Unsterile Product 9 9
Unintended Movement 9 9
Detachment of Device or Device Component 8 8
Manufacturing, Packaging or Shipping Problem 8 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
Device Contaminated During Manufacture or Shipping 5 5
Firing Problem 5 5
Ejection Problem 5 5
Failure to Align 5 5
Output Problem 4 4
Device Markings/Labelling Problem 4 4
Device Damaged Prior to Use 4 4
Material Separation 4 4
Component Missing 4 4
Improper or Incorrect Procedure or Method 4 4
Material Discolored 3 3
No Apparent Adverse Event 3 3
Activation Problem 3 3
Stretched 3 3
Device Slipped 3 3
Insufficient Information 2 2
Sharp Edges 2 2
Loose or Intermittent Connection 2 2
Material Rupture 2 2
Mechanics Altered 2 2
Pressure Problem 2 2
Difficult to Open or Close 2 2
Structural Problem 2 2
Particulates 2 2
Output above Specifications 2 2
Device Displays Incorrect Message 2 2
Product Quality Problem 2 2
Difficult to Remove 2 2
Migration or Expulsion of Device 2 2
Patient-Device Incompatibility 1 1
Material Disintegration 1 1
Optical Decentration 1 1
Corroded 1 1
Unstable 1 1
Device Fell 1 1
Failure to Fire 1 1
Tear, Rip or Hole in Device Packaging 1 1
Difficult or Delayed Positioning 1 1
Connection Problem 1 1
Misassembled 1 1
Self-Activation or Keying 1 1
Material Frayed 1 1
Obstruction of Flow 1 1
Material Invagination 1 1
Device Tipped Over 1 1
Inadequacy of Device Shape and/or Size 1 1
Dent in Material 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Failure to Infuse 1 1
Contamination of Device Ingredient or Reagent 1 1
Unintended Collision 1 1
Device-Device Incompatibility 1 1
Peeled/Delaminated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 719 729
No Known Impact Or Consequence To Patient 527 548
Insufficient Information 378 391
No Consequences Or Impact To Patient 252 365
Capsular Bag Tear 59 59
No Code Available 44 44
No Patient Involvement 41 41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 39 39
Failure of Implant 28 28
Corneal Edema 23 23
Eye Injury 22 22
Blurred Vision 16 16
Visual Disturbances 13 13
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
Hypopyon 3 3
Zonular Dehiscence 3 3
Device Embedded In Tissue or Plaque 3 3
Unspecified Infection 3 3
Headache 3 3
Conjunctivitis 2 2
Hyperemia 2 2
Hyphema 2 2
Vitreous Floaters 2 2
Blood Loss 2 2
Patient Problem/Medical Problem 2 2
Injury 2 2
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
Toxic Anterior Segment Syndrome (TASS) 1 1
Swelling/ Edema 1 1
Glaucoma 1 1
Corneal Clouding/Hazing 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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