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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fluid, intraocular
Regulation Description Intraocular fluid.
Product CodeLWL
Regulation Number 886.4275
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
3 1 11 2 1 0

MDR Year MDR Reports MDR Events
2021 12 12
2022 13 13
2023 18 18
2024 16 16
2025 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 64 64
Appropriate Term/Code Not Available 8 8
Patient-Device Incompatibility 5 5
Air/Gas in Device 2 2
Break 1 1
Off-Label Use 1 1
Use of Device Problem 1 1
Particulates 1 1
Packaging Problem 1 1
Product Quality Problem 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 26 26
Visual Impairment 18 18
Blurred Vision 15 15
Retinal Detachment 15 15
Loss of Vision 11 11
Cataract 7 7
Toxic Anterior Segment Syndrome (TASS) 7 7
Retinal Degeneration 7 7
Inflammation 7 7
Intraocular Pressure Increased 5 5
Intraocular Pressure Decreased 5 5
Vitreous Hemorrhage 4 4
Retinal Tear 3 3
Hypopyon 3 3
Macular Edema 3 3
Eye Injury 3 3
Unspecified Eye / Vision Problem 3 3
Uveitis 2 2
Eye Pain 2 2
Pupillary Block 2 2
Pulmonary Edema 2 2
Visual Disturbances 2 2
Dry Eye(s) 2 2
Ischemia 2 2
Endophthalmitis 2 2
Red Eye(s) 2 2
Vitreous Detachment 2 2
Cardiac Arrest 1 1
Retinal Injury 1 1
Foreign Body Reaction 1 1
Capsular Bag Tear 1 1
Eye Burn 1 1
Microcystic Edema 1 1
Optical Nerve Damage 1 1
Insufficient Information 1 1
Scar Tissue 1 1
Dizziness 1 1
Chemosis 1 1
Corneal Edema 1 1
Failure of Implant 1 1
Vitreous Floaters 1 1
Hypoxia 1 1
Hypersensitivity/Allergic reaction 1 1
Hemorrhage/Bleeding 1 1
Irritability 1 1
Stacking Breaths 1 1
Foreign Body Sensation in Eye 1 1
Infiltration into Tissue 1 1
Headache 1 1
Corneal Scar 1 1

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