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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ophthalmic sealant
Definition An ophthalmic sealant is intended to maintain an incision closure and aid in preventing fluid egress from incisions in the eye.
Product CodePFZ
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021
1 0 0 1 3 0

MDR Year MDR Reports MDR Events
2018 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Endophthalmitis 2 2

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