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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)
2016 2017 2018 2019 2020 2021 2022 2023 2024
12 18 8 5 13 15 8 13 4

MDR Year MDR Reports MDR Events
2016 136 136
2017 162 162
2018 113 113
2019 156 156
2020 132 132
2021 157 157
2022 184 184
2023 107 107
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 590 590
Contamination 124 124
Device Contamination with Chemical or Other Material 107 107
Insufficient Information 72 72
Appropriate Term/Code Not Available 47 47
Detachment of Device or Device Component 26 26
Device Contaminated During Manufacture or Shipping 22 22
Difficult to Remove 18 18
Leak/Splash 17 17
Disconnection 16 16
Particulates 15 15
Mechanical Problem 14 14
Contamination /Decontamination Problem 12 12
Delivered as Unsterile Product 12 12
Patient-Device Incompatibility 11 11
Manufacturing, Packaging or Shipping Problem 11 11
Device Operates Differently Than Expected 10 10
Break 7 7
Separation Problem 7 7
Detachment Of Device Component 7 7
Device Handling Problem 5 5
Positioning Problem 5 5
Device Markings/Labelling Problem 5 5
Product Quality Problem 5 5
Material Integrity Problem 3 3
Obstruction of Flow 3 3
Use of Device Problem 3 3
Connection Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Operating System Becomes Nonfunctional 2 2
Burst Container or Vessel 2 2
Split 2 2
Failure to Align 2 2
Microbial Contamination of Device 2 2
Material Separation 2 2
Material Fragmentation 2 2
Complete Blockage 2 2
Material Opacification 2 2
Physical Resistance/Sticking 2 2
Material Deformation 2 2
Contamination of Device Ingredient or Reagent 2 2
Optical Problem 1 1
Therapy Delivered to Incorrect Body Area 1 1
Device Contamination With Biological Material 1 1
Loss of Power 1 1
Unsealed Device Packaging 1 1
Device Packaging Compromised 1 1
Device Emits Odor 1 1
Fluid/Blood Leak 1 1
Torn Material 1 1
Crack 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Overheating of Device 1 1
Labelling, Instructions for Use or Training Problem 1 1
Shelf Life Exceeded 1 1
Packaging Problem 1 1
Sharp Edges 1 1
Fungus in Device Environment 1 1
Scratched Material 1 1
Precipitate in Device or Device Ingredient 1 1
Human-Device Interface Problem 1 1
Device Contaminated at the User Facility 1 1
Tear, Rip or Hole in Device Packaging 1 1
Defective Component 1 1
Occlusion Within Device 1 1
Chemical Problem 1 1
Coagulation in Device or Device Ingredient 1 1
Component Missing 1 1
Degraded 1 1
Unintended Ejection 1 1
Device Dislodged or Dislocated 1 1
No Apparent Adverse Event 1 1
Structural Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Intraocular Pressure Increased 210 210
No Clinical Signs, Symptoms or Conditions 142 142
No Consequences Or Impact To Patient 135 135
Inflammation 115 115
Toxic Anterior Segment Syndrome (TASS) 101 101
No Code Available 97 97
Corneal Edema 97 97
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 90 90
Endophthalmitis 88 88
No Known Impact Or Consequence To Patient 72 72
Uveitis 53 53
Blurred Vision 46 46
Capsular Bag Tear 40 40
Pain 37 37
Visual Impairment 33 33
Eye Burn 30 30
Toxicity 30 30
Eye Injury 26 26
Hyphema 24 24
Hypopyon 21 21
Vitrectomy 20 20
Loss of Vision 19 19
Foreign Body In Patient 19 19
No Information 17 17
Eye Pain 17 17
Conjunctivitis 15 15
Unspecified Infection 14 14
No Patient Involvement 14 14
Clouding, Central Corneal 12 12
Hemorrhage/Bleeding 11 11
Iritis 9 9
Intraocular Pressure Decreased 9 9
Vitritis 8 8
Vitreous Loss 8 8
Red Eye(s) 7 7
Corneal Decompensation 7 7
Headache 7 7
Macular Edema 7 7
Fibrosis 7 7
Irritation 6 6
Nausea 6 6
Visual Disturbances 6 6
Reaction 6 6
Rupture 5 5
Vitreous Floaters 5 5
Bacterial Infection 4 4
Injury 4 4
Burn, Thermal 4 4
Keratitis 4 4
Device Embedded In Tissue or Plaque 4 4
Eye Infections 4 4
Complaint, Ill-Defined 3 3
Zonular Dehiscence 3 3
Retinal Detachment 3 3
Vitreous Hemorrhage 3 3
Cataract 3 3
Intraocular Infection 3 3
Corneal Clouding/Hazing 3 3
Glaucoma 2 2
Hyperemia 2 2
Intraocular Pressure, Delayed, Uncontrolled 2 2
Corneal Abrasion 2 2
Corneal Stromal Edema 2 2
Edema 2 2
Vomiting 2 2
Itching Sensation 2 2
Perforation 2 2
Discomfort 2 2
Patient Problem/Medical Problem 2 2
Swelling/ Edema 2 2
Insufficient Information 1 1
Respiratory Insufficiency 1 1
Excessive Tear Production 1 1
Anxiety 1 1
Discharge 1 1
Blood Loss 1 1
Skin Inflammation 1 1
Occlusion 1 1
Scarring 1 1
Swelling 1 1
Toxic Shock Syndrome 1 1
Burning Sensation 1 1
Foreign Body Sensation in Eye 1 1
Erythema 1 1
Infarction, Cerebral 1 1
Burn(s) 1 1
Capsular Contracture 1 1
Adhesion(s) 1 1
Autoimmune Reaction 1 1
Ischemia 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 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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