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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)
2021 2022 2023 2024 2025 2026
15 8 13 10 13 1

MDR Year MDR Reports MDR Events
2021 157 157
2022 184 184
2023 107 107
2024 96 107
2025 95 102
2026 65 67

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 439 441
Contamination 126 140
Device Contaminated During Manufacture or Shipping 22 22
Appropriate Term/Code Not Available 22 22
Particulates 16 16
Mechanical Problem 15 17
Manufacturing, Packaging or Shipping Problem 15 15
Delivered as Unsterile Product 13 13
Defective Component 10 10
Device Contamination with Chemical or Other Material 10 10
Detachment of Device or Device Component 7 7
Device Handling Problem 4 4
Fitting Problem 3 3
Use of Device Problem 3 4
Product Quality Problem 3 3
Operating System Becomes Nonfunctional 2 2
Physical Resistance/Sticking 2 2
Material Integrity Problem 2 2
Difficult to Remove 2 2
Device Difficult to Setup or Prepare 2 2
Improper Flow or Infusion 2 2
Device Dislodged or Dislocated 2 2
Leak/Splash 1 1
Separation Problem 1 1
Crack 1 1
Complete Blockage 1 1
Expiration Date Error 1 2
Therapeutic or Diagnostic Output Failure 1 1
Air/Gas in Device 1 1
Precipitate in Device or Device Ingredient 1 1
Structural Problem 1 1
Material Separation 1 1
Connection Problem 1 1
Device Contaminated at the User Facility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 209 225
Toxic Anterior Segment Syndrome (TASS) 147 147
Intraocular Pressure Increased 117 117
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 108 108
Endophthalmitis 74 74
Blurred Vision 73 73
Corneal Edema 70 70
Inflammation 59 59
Uveitis 58 58
Hypopyon 41 41
Eye Pain 31 31
Capsular Bag Tear 27 27
Loss of Vision 26 26
Eye Burn 26 26
Eye Injury 24 25
Hyphema 22 23
Conjunctivitis 22 22
Vitritis 20 20
Visual Impairment 18 18
Iritis 16 16
Intraocular Pressure Decreased 15 15
Insufficient Information 11 11
Vitreous Floaters 9 9
Corneal Clouding/Hazing 7 7
Hyperemia 7 7
Fibrosis 7 7
Red Eye(s) 7 7
Retinal Detachment 7 7
Headache 6 6
Macular Edema 5 5
Eye Infections 5 5
Vitreous Hemorrhage 5 5
Keratitis 5 5
Foreign Body In Patient 5 5
Hemorrhage/Bleeding 4 4
Swelling/ Edema 4 4
Visual Disturbances 3 3
Zonular Dehiscence 3 3
Cataract 3 3
Bacterial Infection 3 3
Glaucoma 2 2
Vomiting 2 2
Unspecified Eye / Vision Problem 2 2
Corneal Stromal Edema 2 2
Intraocular Infection 2 2
Retinal Degeneration 2 2
No Code Available 2 2
Nausea 2 2
Corneal Perforation 2 3
Retinal Tear 2 2

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