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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
Regulation Description Intraocular fluid.
Product CodeLZP
Regulation Number 886.4275
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
18 8 5 13 15 0

MDR Year MDR Reports MDR Events
2017 162 162
2018 113 113
2019 156 156
2020 132 132
2021 156 156

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 376 376
Device Contamination with Chemical or Other Material 71 71
Contamination 62 62
Appropriate Term/Code Not Available 29 29
Insufficient Information 25 25
Device Contaminated During Manufacture or Shipping 22 22
Detachment of Device or Device Component 21 21
Leak/Splash 17 17
Disconnection 16 16
Difficult to Remove 16 16
Contamination /Decontamination Problem 12 12
Particulates 7 7
Mechanical Problem 7 7
Break 6 6
Patient-Device Incompatibility 6 6
Separation Problem 6 6
Device Operates Differently Than Expected 5 5
Detachment Of Device Component 5 5
Positioning Problem 4 4
Device Handling Problem 3 3
Obstruction of Flow 3 3
Failure to Align 2 2
Material Separation 2 2
Burst Container or Vessel 2 2
Delivered as Unsterile Product 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Deformation 2 2
Optical Problem 1 1
Packaging Problem 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Human-Device Interface Problem 1 1
Sharp Edges 1 1
Scratched Material 1 1
Torn Material 1 1
No Apparent Adverse Event 1 1
Device Contaminated at the User Facility 1 1
Occlusion Within Device 1 1
Device Emits Odor 1 1
Material Opacification 1 1
Overheating of Device 1 1
Unsealed Device Packaging 1 1
Coagulation in Device or Device Ingredient 1 1
Crack 1 1
Degraded 1 1
Unintended Ejection 1 1
Fluid Leak 1 1
Material Fragmentation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Shelf Life Exceeded 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Fungus in Device Environment 1 1
Tear, Rip or Hole in Device Packaging 1 1
Precipitate in Device or Device Ingredient 1 1
Product Quality Problem 1 1
Therapy Delivered to Incorrect Body Area 1 1
Structural Problem 1 1
Device Packaging Compromised 1 1
Contamination of Device Ingredient or Reagent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Intraocular Pressure Increased 142 142
No Consequences Or Impact To Patient 119 119
Inflammation 84 84
No Code Available 82 82
Corneal Edema 56 56
No Known Impact Or Consequence To Patient 55 55
Toxic Anterior Segment Syndrome (TASS) 53 53
No Clinical Signs, Symptoms or Conditions 45 45
Endophthalmitis 43 43
Capsular Bag Tear 28 28
Pain 26 26
Visual Impairment 20 20
Eye Injury 20 20
Eye Burn 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Vitrectomy 17 17
Hyphema 16 16
No Information 15 15
Hypopyon 14 14
Uveitis 13 13
Unspecified Infection 12 12
Blurred Vision 11 11
Clouding, Central Corneal 11 11
Foreign Body In Patient 11 11
Loss of Vision 10 10
No Patient Involvement 9 9
Vitritis 8 8
Hemorrhage/Bleeding 8 8
Irritation 6 6
Nausea 6 6
Iritis 5 5
Corneal Decompensation 5 5
Rupture 5 5
Toxicity 5 5
Injury 4 4
Visual Disturbances 4 4
Vitreous Loss 4 4
Conjunctivitis 4 4
Headache 4 4
Red Eye(s) 3 3
Retinal Detachment 3 3
Vitreous Hemorrhage 3 3
Reaction 3 3
Burn, Thermal 3 3
Intraocular Pressure Decreased 3 3
Swelling/ Edema 2 2
Eye Infections 2 2
Eye Pain 2 2
Device Embedded In Tissue or Plaque 2 2
Fibrosis 2 2
Discomfort 2 2
Keratitis 2 2
Perforation 2 2
Intraocular Pressure, Delayed, Uncontrolled 2 2
Corneal Abrasion 2 2
Edema 2 2
Corneal Stromal Edema 2 2
Hyperemia 1 1
High Blood Pressure/ Hypertension 1 1
Foreign Body Sensation in Eye 1 1
Glaucoma 1 1
Corneal Clouding/Hazing 1 1
Macular Edema 1 1
Adhesion(s) 1 1
Autoimmune Reaction 1 1
Burn(s) 1 1
Capsular Contracture 1 1
Infarction, Cerebral 1 1
Intraocular Infection 1 1
Scarring 1 1
Swelling 1 1
Toxic Shock Syndrome 1 1
Occlusion 1 1
Ischemia 1 1
Complaint, Ill-Defined 1 1
Zonular Dehiscence 1 1
Blood Loss 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical Optics Inc. (AMO) II May-10-2017
2 Johnson & Johnson Surgical Vision Inc II Jan-27-2020
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