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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)
2020 2021 2022 2023 2024 2025
13 15 8 13 10 6

MDR Year MDR Reports MDR Events
2020 132 132
2021 157 157
2022 184 184
2023 107 107
2024 96 107
2025 34 38

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 439 440
Contamination 110 120
Appropriate Term/Code Not Available 29 29
Device Contaminated During Manufacture or Shipping 22 22
Detachment of Device or Device Component 18 18
Particulates 17 17
Manufacturing, Packaging or Shipping Problem 14 14
Mechanical Problem 13 15
Delivered as Unsterile Product 12 12
Device Contamination with Chemical or Other Material 12 12
Difficult to Remove 7 7
Positioning Problem 4 4
Fitting Problem 3 3
Obstruction of Flow 3 3
Product Quality Problem 3 3
Operating System Becomes Nonfunctional 2 2
Break 2 2
Physical Resistance/Sticking 2 2
Defective Component 2 2
Use of Device Problem 2 3
Failure to Align 2 2
Material Separation 2 2
Leak/Splash 1 1
Separation Problem 1 1
Crack 1 1
Complete Blockage 1 1
Patient-Device Incompatibility 1 1
Insufficient Information 1 1
Expiration Date Error 1 2
Material Integrity Problem 1 1
Contamination /Decontamination Problem 1 1
Air/Gas in Device 1 1
Precipitate in Device or Device Ingredient 1 1
Sharp Edges 1 1
Material Deformation 1 1
No Apparent Adverse Event 1 1
Device Dislodged or Dislocated 1 1
Coagulation in Device or Device Ingredient 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 171 183
Intraocular Pressure Increased 128 128
Toxic Anterior Segment Syndrome (TASS) 118 118
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 102 102
Endophthalmitis 79 79
Inflammation 66 66
Corneal Edema 65 65
Blurred Vision 62 62
Uveitis 59 59
No Consequences Or Impact To Patient 34 34
Hypopyon 33 33
Eye Burn 30 30
Eye Pain 23 23
No Code Available 23 23
Hyphema 23 24
Capsular Bag Tear 22 22
Loss of Vision 20 20
Visual Impairment 20 20
Eye Injury 19 20
Vitritis 18 18
Conjunctivitis 14 14
Iritis 12 12
No Information 12 12
Intraocular Pressure Decreased 11 11
Vitreous Floaters 9 9
Hyperemia 7 7
Fibrosis 7 7
Insufficient Information 7 7
No Known Impact Or Consequence To Patient 7 7
Headache 6 6
Pain 6 6
Foreign Body In Patient 6 6
Corneal Clouding/Hazing 6 6
Vitrectomy 5 5
Clouding, Central Corneal 5 5
Keratitis 5 5
Hemorrhage/Bleeding 5 5
Macular Edema 5 5
Retinal Detachment 4 4
Swelling/ Edema 4 4
Vitreous Hemorrhage 4 4
Eye Infections 4 4
Zonular Dehiscence 3 3
Visual Disturbances 3 3
Rupture 3 3
Cataract 3 3
Excessive Tear Production 2 2
Retinal Tear 2 2
Unspecified Infection 2 2
Corneal Perforation 2 3

Recalls
Manufacturer Recall Class Date Posted
1 Johnson & Johnson Surgical Vision Inc II Jan-27-2020
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