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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
2014 21 21
2015 17 17
2016 17 17
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 86 86
Wireless Communication Problem 3 3
No Device Output 2 2
Device Inoperable 1 1
Connection Problem 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Erosion 21 21
Retinal Detachment 19 19
Intraocular Pressure, Delayed, Uncontrolled 14 14
No Code Available 13 13
Hemorrhage/Bleeding 11 11
Wound Dehiscence 8 8
Hyphema 7 7
Endophthalmitis 6 6
Intraocular Pressure Increased 5 5
Pain 5 5
Inflammation 4 4
Chemosis 4 4
Loss of Vision 3 3
No Known Impact Or Consequence To Patient 3 3
Fibrosis 3 3
Eye Injury 2 2
Neovascularization 2 2
Retinal Tear 1 1
Irritation 1 1
Hypopyon 1 1
Fall 1 1
Failure to Anastomose 1 1
Corneal Edema 1 1
Cyclitis 1 1
Corneal Infiltrates 1 1

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