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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cannula, trocar, ophthalmic
Regulation Description Manual ophthalmic surgical instrument.
Definition The trocar/cannula set is a manual surgical instrument intended for use as single-use, disposable cannula system for establishing an entry site conduit for passing ophthalmic instruments used to perform posterior ophthalmic surgical procedures.
Product CodeNGY
Regulation Number 886.4350
Device Class 1

Device Problems
Leak / Splash 12
Trocar 9
Valve 6
Device Operational Issue 3
Adverse Event Without Identified Device or Use Problem 2
Cannula 2
Detachment Of Device Component 1
Fluid Leak 1
Device Operates Differently Than Expected 1
Device Contamination with Chemical or Other Material 1
Total Device Problems 38

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research, Ltd. II May-18-2016

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