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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
2017 334 334
2018 592 592
2019 703 757
2020 335 408
2021 349 369
2022 103 103

Device Problems MDRs with this Device Problem Events in those MDRs
Break 347 364
Crack 235 341
Scratched Material 192 192
Device Contamination with Chemical or Other Material 136 136
Defective Device 123 123
Failure to Eject 121 121
Device Damaged by Another Device 111 145
Contamination 110 110
Physical Resistance/Sticking 100 100
Adverse Event Without Identified Device or Use Problem 77 77
Material Split, Cut or Torn 70 70
Activation, Positioning or SeparationProblem 70 70
Failure to Advance 67 67
Positioning Failure 61 61
Defective Component 53 53
Device Operates Differently Than Expected 53 53
Appropriate Term/Code Not Available 51 51
Material Deformation 50 50
Positioning Problem 50 50
Difficult or Delayed Positioning 44 44
Inaccurate Delivery 42 42
Material Twisted/Bent 41 41
Mechanical Jam 41 41
Difficult to Advance 27 27
Entrapment of Device 27 27
Mechanical Problem 26 26
Material Integrity Problem 26 26
Sticking 24 24
Failure to Unfold or Unwrap 24 24
Failure to Deliver 23 23
Torn Material 22 22
Malposition of Device 22 22
Split 22 22
Unintended Ejection 20 20
Difficult to Insert 19 19
Therapeutic or Diagnostic Output Failure 19 19
Physical Resistance 18 18
Contamination /Decontamination Problem 17 17
Unintended Movement 16 16
Insufficient Information 16 16
Premature Activation 15 15
Bent 14 14
Difficult to Fold, Unfold or Collapse 12 12
Device Difficult to Setup or Prepare 12 12
Improper or Incorrect Procedure or Method 11 11
Detachment of Device or Device Component 11 11
Device Dislodged or Dislocated 11 11
Stretched 10 10
Material Rupture 10 10
Use of Device Problem 9 9
Material Fragmentation 9 9
Delivered as Unsterile Product 8 8
Failure to Fold 8 8
Partial Blockage 8 8
Material Too Rigid or Stiff 8 8
Deformation Due to Compressive Stress 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Firing Problem 7 7
Detachment Of Device Component 7 7
Material Frayed 6 6
Component Missing 6 6
Material Separation 6 6
Pressure Problem 6 6
Output Problem 5 5
Ejection Problem 5 5
Device Contaminated During Manufacture or Shipping 5 5
Device Displays Incorrect Message 5 5
Misfire 5 5
Failure to Align 5 5
Difficult to Remove 5 5
Device Slipped 5 5
Device Damaged Prior to Use 4 4
Migration or Expulsion of Device 4 4
Dent in Material 4 4
Mechanics Altered 4 4
Material Protrusion/Extrusion 3 3
Material Distortion 3 3
No Apparent Adverse Event 3 3
Activation Problem 3 3
Device Markings/Labelling Problem 3 3
Material Discolored 3 3
Inadequacy of Device Shape and/or Size 3 3
Loose or Intermittent Connection 2 2
Product Quality Problem 2 2
Particulates 2 2
Unstable 2 2
Metal Shedding Debris 2 2
Output above Specifications 2 2
Hole In Material 2 2
Kinked 2 2
Folded 2 2
Patient-Device Incompatibility 2 2
Difficult to Open or Close 2 2
Device-Device Incompatibility 2 2
Structural Problem 2 2
Separation Failure 2 2
Sharp Edges 2 2
Device Fell 1 1
Noise, Audible 1 1
Explosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 936 957
No Consequences Or Impact To Patient 458 571
No Clinical Signs, Symptoms or Conditions 372 382
No Patient Involvement 148 148
No Code Available 111 111
Insufficient Information 87 100
Capsular Bag Tear 74 74
Failure of Implant 36 36
No Information 27 27
Eye Injury 26 26
Corneal Edema 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Rupture 21 22
Foreign Body In Patient 20 20
Inflammation 19 19
Visual Impairment 13 13
Tissue Damage 12 12
Blurred Vision 11 11
Visual Disturbances 10 10
Vitrectomy 9 9
Edema 8 8
Endophthalmitis 8 8
Intraocular Pressure Increased 6 6
Discomfort 6 7
Device Embedded In Tissue or Plaque 6 6
Injury 5 5
Prolapse 5 5
Hemorrhage/Bleeding 4 5
Unspecified Infection 4 4
Hypopyon 4 4
Hyphema 3 3
Swelling 3 3
Pain 3 3
Uveitis 3 3
Patient Problem/Medical Problem 3 3
Halo 3 3
Complaint, Ill-Defined 2 2
Blood Loss 2 2
Eye Pain 2 2
Loss of Vision 2 2
Therapeutic Effects, Unexpected 2 2
Corneal Abrasion 2 2
Macular Edema 1 1
Dry Eye(s) 1 1
Vessel Or Plaque, Device Embedded In 1 1
Chemosis 1 1
Hyperemia 1 1
High Blood Pressure/ Hypertension 1 1
Vitreous Floaters 1 1
Headache 1 1
Laceration(s) 1 1
Pneumonia 1 1
Retinal Detachment 1 1
Retinal Tear 1 1
Scar Tissue 1 1
Sepsis 1 1
Shock 1 1
Discharge 1 1
Toxic Anterior Segment Syndrome (TASS) 1 1
Excessive Tear Production 1 1
Viral Infection 1 1
Collapse 1 1
Vitreous Detachment 1 1
Needle Stick/Puncture 1 1
Intraoperative Pain 1 1
Organ Dehiscence 1 1

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