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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)
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
11 12 18 8 5 13 15 8 13 8

MDR Year MDR Reports MDR Events
2015 68 68
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 53 55

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 619 619
Contamination 134 136
Device Contamination with Chemical or Other Material 128 128
Insufficient Information 83 83
Appropriate Term/Code Not Available 48 48
Detachment of Device or Device Component 30 30
Device Contaminated During Manufacture or Shipping 22 22
Particulates 20 20
Difficult to Remove 18 18
Leak/Splash 17 17
Disconnection 16 16
Mechanical Problem 14 14
Detachment Of Device Component 13 13
Device Operates Differently Than Expected 13 13
Patient-Device Incompatibility 12 12
Contamination /Decontamination Problem 12 12
Delivered as Unsterile Product 12 12
Manufacturing, Packaging or Shipping Problem 11 11
Separation Problem 7 7
Break 7 7
Product Quality Problem 5 5
Device Markings/Labelling Problem 5 5
Positioning Problem 5 5
Device Handling Problem 5 5
Use of Device Problem 4 4
Material Integrity Problem 3 3
Contamination of Device Ingredient or Reagent 3 3
Obstruction of Flow 3 3
Temperature Problem 2 2
Connection Problem 2 2
Material Separation 2 2
Complete Blockage 2 2
Material Opacification 2 2
Burst Container or Vessel 2 2
Physical Resistance/Sticking 2 2
Improper or Incorrect Procedure or Method 2 2
Use of Incorrect Control/Treatment Settings 2 2
Packaging Problem 2 2
Material Deformation 2 2
Material Fragmentation 2 2
Failure to Align 2 2
Operating System Becomes Nonfunctional 2 2
Occlusion Within Device 2 2
Split 2 2
Component Missing 2 2
Microbial Contamination of Device 2 2
Defective Component 2 2
Therapy Delivered to Incorrect Body Area 1 1
Component Falling 1 1
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Intraocular Pressure Increased 215 215
No Clinical Signs, Symptoms or Conditions 154 156
No Consequences Or Impact To Patient 150 150
Inflammation 130 130
Toxic Anterior Segment Syndrome (TASS) 107 107
No Code Available 105 105
Corneal Edema 101 101
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 94 94
Endophthalmitis 92 92
No Known Impact Or Consequence To Patient 83 83
Uveitis 56 56
Blurred Vision 50 50
Capsular Bag Tear 43 43
Pain 37 37
Eye Burn 34 34
Visual Impairment 33 33
Toxicity 30 30
Eye Injury 27 27
Hyphema 24 24
Loss of Vision 24 24
Foreign Body In Patient 23 23
Hypopyon 23 23
Vitrectomy 22 22
No Information 19 19
Eye Pain 19 19
Conjunctivitis 15 15
No Patient Involvement 15 15
Unspecified Infection 14 14
Clouding, Central Corneal 12 12
Hemorrhage/Bleeding 11 11
Iritis 11 11
Intraocular Pressure Decreased 10 10
Headache 9 9
Vitreous Loss 9 9
Vitritis 9 9
Fibrosis 8 8
Macular Edema 8 8
Vitreous Floaters 8 8
Red Eye(s) 8 8
Corneal Decompensation 7 7
Rupture 7 7
Visual Disturbances 7 7
Reaction 7 7
Keratitis 6 6
Nausea 6 6
Irritation 6 6
Vitreous Hemorrhage 6 6
Bacterial Infection 5 5
Burn, Thermal 5 5
Injury 5 5

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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