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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
Delivered as Unsterile Product 12 12
Contamination /Decontamination Problem 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
Use of Device Problem 3 3
Obstruction of Flow 3 3
Connection Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Burst Container or Vessel 2 2
Operating System Becomes Nonfunctional 2 2
Microbial Contamination of Device 2 2
Failure to Align 2 2
Split 2 2
Material Separation 2 2
Complete Blockage 2 2
Material Fragmentation 2 2
Material Opacification 2 2
Physical Resistance/Sticking 2 2
Contamination of Device Ingredient or Reagent 2 2
Material Deformation 2 2
Optical Problem 1 1
Device Contamination With Biological Material 1 1
Therapy Delivered to Incorrect Body Area 1 1
Unsealed Device Packaging 1 1
Loss of Power 1 1
Device Emits Odor 1 1
Device Packaging Compromised 1 1
Overheating of Device 1 1
Shelf Life Exceeded 1 1
Crack 1 1
Fluid/Blood Leak 1 1
Labelling, Instructions for Use or Training Problem 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Packaging Problem 1 1
Torn Material 1 1
Fungus in Device Environment 1 1
Scratched Material 1 1
Sharp Edges 1 1
Precipitate in Device or Device Ingredient 1 1
Human-Device Interface Problem 1 1
Defective Component 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Contaminated at the User Facility 1 1
Occlusion Within Device 1 1
Chemical Problem 1 1
Coagulation in Device or Device Ingredient 1 1
Structural Problem 1 1
Device Dislodged or Dislocated 1 1
No Apparent Adverse Event 1 1
Component Missing 1 1
Degraded 1 1
Unintended Ejection 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
Corneal Edema 97 97
No Code Available 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
Eye Pain 17 17
No Information 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
Vitreous Loss 8 8
Vitritis 8 8
Fibrosis 7 7
Red Eye(s) 7 7
Corneal Decompensation 7 7
Macular Edema 7 7
Headache 7 7
Visual Disturbances 6 6
Irritation 6 6
Nausea 6 6
Reaction 6 6
Vitreous Floaters 5 5
Rupture 5 5
Eye Infections 4 4
Device Embedded In Tissue or Plaque 4 4
Injury 4 4
Burn, Thermal 4 4
Keratitis 4 4
Bacterial Infection 4 4
Vitreous Hemorrhage 3 3
Zonular Dehiscence 3 3
Retinal Detachment 3 3
Intraocular Infection 3 3
Cataract 3 3
Complaint, Ill-Defined 3 3
Corneal Clouding/Hazing 3 3
Corneal Stromal Edema 2 2
Corneal Abrasion 2 2
Hyperemia 2 2
Intraocular Pressure, Delayed, Uncontrolled 2 2
Perforation 2 2
Vomiting 2 2
Discomfort 2 2
Itching Sensation 2 2
Glaucoma 2 2
Edema 2 2
Patient Problem/Medical Problem 2 2
Swelling/ Edema 2 2
Respiratory Insufficiency 1 1
Infarction, Cerebral 1 1
Foreign Body Sensation in Eye 1 1
Hypersensitivity/Allergic reaction 1 1
Occlusion 1 1
Skin Inflammation 1 1
Capsular Contracture 1 1
Scarring 1 1
Blood Loss 1 1
Toxic Shock Syndrome 1 1
Autoimmune Reaction 1 1
Erythema 1 1
High Blood Pressure/ Hypertension 1 1
Insufficient Information 1 1
Swelling 1 1
Discharge 1 1
Burn(s) 1 1
Ischemia 1 1
Excessive Tear Production 1 1
Burning Sensation 1 1
Adhesion(s) 1 1
Anxiety 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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