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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sponge, ophthalmic
Regulation Description Ophthalmic sponge.
Product CodeHOZ
Regulation Number 886.4790
Device Class 2

MDR Year MDR Reports MDR Events
2015 1 1
2016 2 2
2019 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 2 2
Device Contamination with Chemical or Other Material 1 1
Material Fragmentation 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Itching Sensation 2 2
Pain 1 1
Swelling 1 1
Reaction 1 1
Foreign Body In Patient 1 1
No Information 1 1
Edema 1 1
Erythema 1 1
Hemorrhage/Bleeding 1 1
Irritation 1 1

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