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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
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

MDR Year MDR Reports MDR Events
2019 15 15
2020 9 9
2021 7 7
2022 10 10
2023 32 32
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 26 26
Dull, Blunt 15 15
Leak/Splash 11 11
Fitting Problem 6 6
Detachment of Device or Device Component 3 3
Device Markings/Labelling Problem 2 2
Component Missing 2 2
Material Separation 2 2
Device Slipped 1 1
Use of Device Problem 1 1
Insufficient Flow or Under Infusion 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Material Fragmentation 1 1
Structural Problem 1 1
Device Dislodged or Dislocated 1 1
Gas/Air Leak 1 1
Ejection Problem 1 1
Unintended Ejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 52 52
No Consequences Or Impact To Patient 13 13
No Known Impact Or Consequence To Patient 8 8
Insufficient Information 1 1
Internal Organ Perforation 1 1
Uveitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mani, Inc. - Kiyohara Facility II Apr-26-2023
2 Mani, Inc. - Kiyohara Facility II Dec-10-2020
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