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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
2017 46 46
2018 25 25
2019 15 15
2020 9 9
2021 11 11
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 42 42
Fluid Leak 26 26
Dull, Blunt 9 9
Adverse Event Without Identified Device or Use Problem 4 4
Detachment Of Device Component 4 4
Fitting Problem 3 3
Device Operates Differently Than Expected 3 3
Device Operational Issue 3 3
Break 3 3
Device Slipped 2 2
Detachment of Device or Device Component 2 2
Device Dislodged or Dislocated 2 2
Device Markings/Labelling Problem 2 2
Component Falling 2 2
Material Fragmentation 2 2
Material Separation 2 2
Physical Resistance/Sticking 2 2
Device Contamination with Chemical or Other Material 1 1
Device Inoperable 1 1
Air Leak 1 1
Difficult to Remove 1 1
Loose or Intermittent Connection 1 1
Insufficient Flow or Under Infusion 1 1
Device Damaged Prior to Use 1 1
Structural Problem 1 1
Collapse 1 1
Unintended Ejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 48 48
No Consequences Or Impact To Patient 35 35
No Clinical Signs, Symptoms or Conditions 14 14
No Information 3 3
Endophthalmitis 2 2
Retinal Injury 2 2
Insufficient Information 2 2
Uveitis 1 1
Eye Injury 1 1
Hemorrhage/Bleeding 1 1
No Code Available 1 1
No Patient Involvement 1 1

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