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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device keratome, battery-powered
Product CodeHMY
Regulation Number 886.4370
Device Class 1

MDR Year MDR Reports MDR Events
2020 13 13
2021 7 7
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 18 18
Insufficient Information 3 3
Failure to Clean Adequately 2 2
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Abrasion 19 19
Keratitis 4 4

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