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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, communications, images, ophthalmic
Regulation Description Medical image communications device.
Product CodeNFG
Regulation Number 892.2020
Device Class 1

MDR Year MDR Reports MDR Events
2020 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
Headache 1 1
Red Eye(s) 1 1
Blurred Vision 1 1
Dizziness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research, Ltd. II Apr-14-2016
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