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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device aid, surgical, viscoelastic
Product CodeLZP
Regulation Number 886.4275
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
8 5 13 15 8 2

MDR Year MDR Reports MDR Events
2018 113 113
2019 156 156
2020 132 132
2021 157 157
2022 184 184
2023 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 453 453
Contamination 96 96
Appropriate Term/Code Not Available 33 33
Detachment of Device or Device Component 24 24
Device Contamination with Chemical or Other Material 23 23
Device Contaminated During Manufacture or Shipping 22 22
Difficult to Remove 18 18
Particulates 14 14
Mechanical Problem 13 13
Leak/Splash 12 12
Contamination /Decontamination Problem 12 12
Disconnection 11 11
Insufficient Information 11 11
Delivered as Unsterile Product 10 10
Manufacturing, Packaging or Shipping Problem 9 9
Separation Problem 7 7
Positioning Problem 4 4
Product Quality Problem 4 4
Break 4 4
Obstruction of Flow 3 3
Failure to Align 2 2
Patient-Device Incompatibility 2 2
Material Separation 2 2
Material Deformation 2 2
Detachment Of Device Component 2 2
Operating System Becomes Nonfunctional 2 2
Device Handling Problem 2 2
Physical Resistance/Sticking 2 2
Sharp Edges 1 1
Packaging Problem 1 1
Human-Device Interface Problem 1 1
Scratched Material 1 1
No Apparent Adverse Event 1 1
Device Contaminated at the User Facility 1 1
Unintended Ejection 1 1
Burst Container or Vessel 1 1
Coagulation in Device or Device Ingredient 1 1
Crack 1 1
Therapy Delivered to Incorrect Body Area 1 1
Precipitate in Device or Device Ingredient 1 1
Occlusion Within Device 1 1
Device Emits Odor 1 1
Overheating of Device 1 1
Unsealed Device Packaging 1 1
Material Integrity Problem 1 1
Connection Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Operates Differently Than Expected 1 1
Fungus in Device Environment 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Intraocular Pressure Increased 180 180
No Clinical Signs, Symptoms or Conditions 102 102
Toxic Anterior Segment Syndrome (TASS) 98 98
No Consequences Or Impact To Patient 81 81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 76 76
No Code Available 71 71
Inflammation 63 63
Corneal Edema 59 59
Endophthalmitis 55 55
Uveitis 52 52
No Known Impact Or Consequence To Patient 41 41
Blurred Vision 35 35
Eye Burn 26 26
Capsular Bag Tear 26 26
Eye Injury 21 21
Hyphema 21 21
Pain 21 21
Visual Impairment 20 20
Hypopyon 15 15
Loss of Vision 12 12
No Information 12 12
Eye Pain 11 11
Clouding, Central Corneal 11 11
Conjunctivitis 11 11
Vitrectomy 9 9
Foreign Body In Patient 9 9
Vitritis 8 8
Hemorrhage/Bleeding 8 8
Unspecified Infection 7 7
No Patient Involvement 7 7
Intraocular Pressure Decreased 7 7
Nausea 6 6
Corneal Decompensation 6 6
Iritis 5 5
Irritation 5 5
Rupture 5 5
Visual Disturbances 4 4
Vitreous Loss 4 4
Eye Infections 4 4
Headache 4 4
Corneal Clouding/Hazing 3 3
Macular Edema 3 3
Burn, Thermal 3 3
Vitreous Hemorrhage 3 3
Toxicity 3 3
Injury 2 2
Retinal Detachment 2 2
Vomiting 2 2
Fibrosis 2 2
Swelling/ Edema 2 2
Corneal Stromal Edema 2 2
Vitreous Floaters 2 2
Corneal Abrasion 2 2
Intraocular Pressure, Delayed, Uncontrolled 2 2
Keratitis 2 2
Perforation 2 2
Red Eye(s) 1 1
Occlusion 1 1
Intraocular Infection 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Edema 1 1
Adhesion(s) 1 1
Autoimmune Reaction 1 1
Burn(s) 1 1
Capsular Contracture 1 1
Cataract 1 1
Glaucoma 1 1
Insufficient Information 1 1
Blood Loss 1 1
Zonular Dehiscence 1 1
Device Embedded In Tissue or Plaque 1 1
Burning Sensation 1 1
Toxic Shock Syndrome 1 1
Reaction 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Johnson & Johnson Surgical Vision Inc II Jan-27-2020
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