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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
Regulation Description Intraocular lens guide.
Product CodeKYB
Regulation Number 886.4300
Device Class 1

MDR Year MDR Reports MDR Events
2016 256 256
2017 334 334
2018 591 591
2019 703 757
2020 335 408
2021 272 292

Device Problems MDRs with this Device Problem Events in those MDRs
Break 385 402
Crack 244 350
Scratched Material 181 181
Device Contamination with Chemical or Other Material 164 164
Defective Device 114 114
Contamination 103 103
Physical Resistance/Sticking 98 98
Adverse Event Without Identified Device or Use Problem 78 78
Device Damaged by Another Device 76 110
Appropriate Term/Code Not Available 76 76
Failure to Eject 76 76
Positioning Failure 74 74
Material Deformation 71 71
Activation, Positioning or SeparationProblem 70 70
Device Operates Differently Than Expected 69 69
Material Split, Cut or Torn 64 64
Difficult or Delayed Positioning 63 63
Failure to Advance 58 58
Positioning Problem 53 53
Defective Component 49 49
Material Twisted/Bent 39 39
Mechanical Jam 36 36
Inaccurate Delivery 34 34
Torn Material 31 31
Entrapment of Device 30 30
Split 29 29
Insufficient Information 27 27
Sticking 26 26
Material Integrity Problem 26 26
Difficult to Advance 24 24
Mechanical Problem 24 24
Bent 24 24
Failure to Deliver 23 23
Physical Resistance 22 22
Malposition of Device 22 22
Difficult to Insert 19 19
Therapeutic or Diagnostic Output Failure 19 19
Failure to Unfold or Unwrap 19 19
Unintended Ejection 18 18
Contamination /Decontamination Problem 17 17
Unintended Movement 17 17
Premature Activation 15 15
Detachment of Device or Device Component 12 12
Improper or Incorrect Procedure or Method 12 12
Material Rupture 11 11
Difficult to Fold, Unfold or Collapse 11 11
Device Dislodged or Dislocated 11 11
Material Fragmentation 10 10
Deformation Due to Compressive Stress 9 9
Stretched 8 8
Material Too Rigid or Stiff 8 8
Partial Blockage 8 8
Detachment Of Device Component 8 8
Delivered as Unsterile Product 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Pressure Problem 7 7
Firing Problem 7 7
Material Separation 7 7
Device Slipped 7 7
Component Missing 7 7
Use of Device Problem 6 6
Migration or Expulsion of Device 6 6
Misfire 6 6
Material Frayed 6 6
Device Damaged Prior to Use 5 5
Failure to Fold 5 5
Device Displays Incorrect Message 5 5
Difficult to Remove 5 5
Failure to Align 5 5
Material Protrusion/Extrusion 5 5
Output Problem 4 4
Hole In Material 4 4
Ejection Problem 4 4
Dent in Material 4 4
Material Distortion 4 4
Mechanics Altered 4 4
Device Markings/Labelling Problem 3 3
Inadequacy of Device Shape and/or Size 3 3
Material Discolored 3 3
Activation Problem 3 3
Device Difficult to Setup or Prepare 3 3
No Apparent Adverse Event 3 3
Delivery System Failure 3 3
Folded 3 3
Patient-Device Incompatibility 2 2
Structural Problem 2 2
Separation Failure 2 2
Obstruction of Flow 2 2
Device Handling Problem 2 2
Difficult to Open or Close 2 2
Metal Shedding Debris 2 2
Burst Container or Vessel 2 2
Kinked 2 2
Loose or Intermittent Connection 2 2
Unstable 2 2
Increase in Pressure 2 2
Product Quality Problem 2 2
Output above Specifications 2 2
Device-Device Incompatibility 2 2
Device Contaminated During Manufacture or Shipping 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 993 1014
No Consequences Or Impact To Patient 524 637
No Clinical Signs, Symptoms or Conditions 240 250
No Patient Involvement 197 197
No Code Available 137 137
Capsular Bag Tear 84 84
Insufficient Information 56 69
Failure of Implant 36 36
No Information 36 36
Eye Injury 34 34
Corneal Edema 30 30
Rupture 25 26
Foreign Body In Patient 22 22
Inflammation 21 21
Tissue Damage 14 14
Blurred Vision 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Vitrectomy 12 12
Visual Impairment 12 12
Visual Disturbances 10 10
Edema 9 9
Endophthalmitis 9 9
Hemorrhage/Bleeding 7 8
Device Embedded In Tissue or Plaque 7 7
Discomfort 6 7
Prolapse 6 6
Injury 5 5
Pain 4 4
Hyphema 4 4
Hypopyon 4 4
Unspecified Infection 4 4
Intraocular Pressure Increased 4 4
Uveitis 3 3
Halo 3 3
Blood Loss 3 3
Patient Problem/Medical Problem 3 3
Swelling 3 3
Therapeutic Effects, Unexpected 2 2
Excessive Tear Production 2 2
Corneal Abrasion 2 2
Complaint, Ill-Defined 2 2
Loss of Vision 2 2
Vitreous Detachment 1 1
Needle Stick/Puncture 1 1
Intraoperative Pain 1 1
Eye Pain 1 1
Toxic Anterior Segment Syndrome (TASS) 1 1
Hyperemia 1 1
Pneumonia 1 1
Retinal Detachment 1 1
Scar Tissue 1 1
Shock 1 1
Laceration(s) 1 1
Headache 1 1
Collapse 1 1
Organ Dehiscence 1 1
Vessel Or Plaque, Device Embedded In 1 1
Cataract 1 1
Chemosis 1 1
Vitreous Loss 1 1
Discharge 1 1
Retinal Tear 1 1
Sepsis 1 1
Dry Eye(s) 1 1
Macular Edema 1 1
Vitreous Floaters 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Staar Surgical Co. II Jun-14-2016
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