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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lens, intraocular, toric optics
Regulation Description Intraocular lens.
Product CodeMJP
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
5 4 1 1 0 1

MDR Year MDR Reports MDR Events
2015 389 389
2016 285 285
2017 311 311
2018 363 363
2019 382 382
2020 123 123

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 402 402
Insufficient Information 265 265
Device Operates Differently Than Expected 196 196
Device Dislodged or Dislocated 154 154
Appropriate Term/Code Not Available 146 146
IOL (Intraocular Lens) Implant 100 100
Scratched Material 100 100
Break 75 75
Malposition of Device 57 57
Patient-Device Incompatibility 48 48
Defective Device 46 46
Positioning Problem 39 39
Unexpected Therapeutic Results 33 33
Crack 28 28
Nonstandard Device 21 21
Defective Component 21 21
Haptic 21 21
Unintended Movement 17 17
Material Opacification 17 17
Device Contamination with Chemical or Other Material 16 16
Migration or Expulsion of Device 15 15
Lenses 14 14
Mechanical Problem 13 13
Material Split, Cut or Torn 13 13
Improper or Incorrect Procedure or Method 13 13
Contamination /Decontamination Problem 11 11
Material Deformation 11 11
Power Problem 11 11
Torn Material 10 10
Therapeutic or Diagnostic Output Failure 9 9
Overcorrection 8 8
Inadequacy of Device Shape and/or Size 8 8
Device Slipped 7 7
Incorrect, Inadequate or Imprecise Resultor Readings 6 6
Difficult to Fold, Unfold or Collapse 6 6
Output Problem 6 6
Material Integrity Problem 6 6
Migration 6 6
Optical Problem 6 6
Failure to Advance 5 5
Device Displays Incorrect Message 5 5
Device Inoperable 5 5
Material Discolored 5 5
Material Twisted/Bent 5 5
Failure to Align 5 5
Component Missing 5 5
Inaccurate Delivery 5 5
Difficult to Remove 4 4
Activation, Positioning or SeparationProblem 4 4
Detachment of Device or Device Component 4 4
Folded 4 4
Contamination 4 4
Unstable 4 4
Device Markings/Labelling Problem 4 4
Physical Resistance/Sticking 4 4
Device Damaged Prior to Use 3 3
Material Rupture 3 3
Leak/Splash 3 3
Packaging Problem 3 3
Out-Of-Box Failure 3 3
Off-Label Use 3 3
Material Too Rigid or Stiff 2 2
Failure to Unfold or Unwrap 2 2
Structural Problem 2 2
Degraded 2 2
Bag 2 2
Failure to Fold 2 2
Mechanical Jam 2 2
Device Damaged by Another Device 2 2
Entrapment of Device 2 2
Product Quality Problem 2 2
Unable to Obtain Readings 2 2
Component Falling 2 2
Sticking 2 2
Mechanics Altered 2 2
Compatibility Problem 2 2
Optical Distortion 2 2
Device Contamination With Biological Material 1 1
Fitting Problem 1 1
Vibration 1 1
Loose or Intermittent Connection 1 1
Poor Quality Image 1 1
Unintended Collision 1 1
Application Program Problem: Power Calculation Error 1 1
Device Subassembly 1 1
Gas Leak 1 1
Optical Discoloration 1 1
Component or Accessory Incompatibility 1 1
Split 1 1
Wrinkled 1 1
Difficult to Insert 1 1
Kinked 1 1
Difficult or Delayed Positioning 1 1
Patient Device Interaction Problem 1 1
Device Alarm System 1 1
Failure To Adhere Or Bond 1 1
Detachment Of Device Component 1 1
Protective Measures Problem 1 1
Positioning Failure 1 1
Energy Output To Patient Tissue Incorrect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 393 393
No Known Impact Or Consequence To Patient 343 343
Blurred Vision 314 314
No Code Available 306 306
Inflammation 129 129
Visual Disturbances 87 87
Endophthalmitis 83 83
Loss of Vision 55 55
Failure of Implant 53 53
Capsular Bag Tear 47 47
Halo 39 39
No Consequences Or Impact To Patient 36 36
No Information 35 35
Complaint, Ill-Defined 34 34
Therapeutic Effects, Unexpected 34 34
Pain 33 35
Vitrectomy 24 24
Corneal Edema 23 24
Dry Eye(s) 20 20
Hypopyon 18 18
Discomfort 17 17
Headache 15 15
Eye Injury 14 14
No Patient Involvement 13 13
Hyperemia 11 11
Intraocular Pressure Increased 11 11
Therapeutic Response, Decreased 11 11
Patient Problem/Medical Problem 10 10
Unspecified Infection 9 9
Red Eye(s) 8 9
Foreign Body Sensation in Eye 8 8
Vitreous Floaters 8 8
Fibrosis 7 7
Foreign Body In Patient 6 6
Capsular Contracture 6 6
Hemorrhage/Bleeding 6 6
Macular Edema 6 6
Increased Sensitivity 6 6
Rupture 6 6
Edema 5 5
Uveitis 5 5
Corneal Clouding/Hazing 4 4
Zonular Dehiscence 4 4
Scar Tissue 3 3
Scarring 3 3
Dizziness 3 3
Vitreous Loss 3 3
Toxicity 3 3
Swelling 3 3
Erythema 3 3
Fatigue 3 3
Flashers 2 2
Glaucoma 2 2
Iritis 2 2
Retinal Tear 2 2
Staphylococcus Aureus 2 2
Fluid Discharge 2 2
Excessive Tear Production 2 2
Itching Sensation 2 2
Keratitis 2 2
Disability 2 2
Reaction 2 2
Vitreous Detachment 2 2
Confusion/ Disorientation 1 1
Blood Loss 1 1
Inadequate Pain Relief 1 1
Depression 1 1
Device Embedded In Tissue or Plaque 1 1
Nausea 1 1
Necrosis 1 1
Optical Nerve Damage 1 1
Adhesion(s) 1 1
Corneal Scar 1 1
Corneal Ulcer 1 1
Bone Fracture(s) 1 1
Clouding, Central Corneal 1 1
Burning Sensation 1 1
Twitching 1 1
Tissue Damage 1 1
Intraocular Infection 1 1
Vertigo 1 1
Joint Dislocation 1 1
Skin Inflammation 1 1
Sleep Dysfunction 1 1
Ambulation Difficulties 1 1
Vitritis 1 1
Discharge 1 1
Irritation 1 1
Perforation 1 1
Retinal Injury 1 1
Hypersensitivity/Allergic reaction 1 1
Microcystic Edema 1 1
Corneal Stromal Edema 1 1
Emotional Changes 1 1
Deposits 1 1
Autoimmune Reaction 1 1
Calcium Deposits/Calcification 1 1
Conjunctivitis 1 1

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