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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 0

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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 408 410
Contamination 105 117
Device Contaminated During Manufacture or Shipping 22 22
Appropriate Term/Code Not Available 20 20
Particulates 16 16
Manufacturing, Packaging or Shipping Problem 14 14
Mechanical Problem 13 15
Delivered as Unsterile Product 13 13
Device Contamination with Chemical or Other Material 10 10
Detachment of Device or Device Component 7 7
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
Defective Component 2 2
Difficult to Remove 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
Material Integrity Problem 1 1
Air/Gas in Device 1 1
Precipitate in Device or Device Ingredient 1 1
Device Handling 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 190 204
Toxic Anterior Segment Syndrome (TASS) 132 132
Intraocular Pressure Increased 115 115
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 104 104
Endophthalmitis 74 74
Blurred Vision 71 71
Corneal Edema 68 68
Uveitis 58 58
Inflammation 56 56
Hypopyon 39 39
Eye Pain 31 31
Eye Burn 25 25
Capsular Bag Tear 25 25
Hyphema 22 23
Conjunctivitis 22 22
Vitritis 20 20
Eye Injury 19 20
Loss of Vision 18 18
Visual Impairment 17 17
Iritis 16 16
Intraocular Pressure Decreased 11 11
Vitreous Floaters 9 9
Hyperemia 7 7
Fibrosis 7 7
Red Eye(s) 7 7
Corneal Clouding/Hazing 6 6
Headache 6 6
Insufficient Information 6 6
Macular Edema 5 5
Keratitis 5 5
Vitreous Hemorrhage 5 5
Foreign Body In Patient 5 5
Retinal Detachment 5 5
Hemorrhage/Bleeding 4 4
Swelling/ Edema 4 4
Eye Infections 4 4
Bacterial Infection 3 3
Zonular Dehiscence 3 3
Cataract 3 3
Vomiting 2 2
Visual Disturbances 2 2
Glaucoma 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
Excessive Tear Production 2 2

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