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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)
2016 2017 2018 2019 2020 2021
0 0 0 1 4 4

MDR Year MDR Reports MDR Events
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Acanthameba Keratitis 1 1

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