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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
2018 25 25
2019 15 15
2020 9 9
2021 11 11
2022 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 21 21
Fluid/Blood Leak 15 15
Dull, Blunt 9 9
Adverse Event Without Identified Device or Use Problem 4 4
Fitting Problem 3 3
Device Operational Issue 3 3
Detachment of Device or Device Component 2 2
Device Markings/Labelling Problem 2 2
Device Operates Differently Than Expected 2 2
Material Separation 2 2
Device Slipped 2 2
Physical Resistance/Sticking 2 2
Ejection Problem 1 1
Device Inoperable 1 1
Structural Problem 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Material Fragmentation 1 1
Loose or Intermittent Connection 1 1
Break 1 1
Collapse 1 1
Component Falling 1 1
Unintended Ejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 23 23
No Clinical Signs, Symptoms or Conditions 20 20
No Known Impact Or Consequence To Patient 18 18
Insufficient Information 2 2
Endophthalmitis 2 2
Retinal Injury 2 2
Uveitis 1 1
Eye Injury 1 1
Hemorrhage/Bleeding 1 1
No Code Available 1 1

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