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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device daily wear soft contact lens to reduce the progression of myopia
Definition Intended to be worn on the surface of the eye in children who have myopia to: • Reduce the rate of progression of myopia, and • Optically correct myopic refractive error.
Product CodeQIT
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
1 4 4 4 7 0

MDR Year MDR Reports MDR Events
2019 1 1
2021 1 1
2022 3 3
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Insufficient Information 2 2
Use of Device Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Acanthameba Keratitis 4 4
Eye Infections 3 3
Eye Pain 2 2
Hypersensitivity/Allergic reaction 2 2
Red Eye(s) 2 2
Anaphylactic Shock 2 2
Corneal Ulcer 2 2
Corneal Clouding/Hazing 1 1
Bacterial Infection 1 1
Corneal Scar 1 1
Visual Impairment 1 1
Loss of Vision 1 1
Visual Disturbances 1 1
Halo 1 1
Keratitis 1 1
Insufficient Information 1 1

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