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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, retinal
Product CodeNBF
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2017 16 16
2018 12 12
2019 7 7
2020 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 34 34
Wireless Communication Problem 2 2
No Device Output 2 2
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Erosion 10 10
Intraocular Pressure, Delayed, Uncontrolled 9 9
Retinal Detachment 7 7
Wound Dehiscence 5 5
No Code Available 4 4
Endophthalmitis 4 4
Hemorrhage/Bleeding 3 3
Hyphema 3 3
Chemosis 3 3
Pain 3 3
No Known Impact Or Consequence To Patient 2 2
Neovascularization 2 2
Intraocular Pressure Increased 2 2
Irritation 1 1
Inflammation 1 1
Corneal Infiltrates 1 1
Fibrosis 1 1

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