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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
2015 16 16
2016 64 64
2017 46 46
2018 25 25
2019 15 15
2020 9 9
2021 7 7
2022 10 10
2023 32 32
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 108 108
Fluid/Blood Leak 48 48
Dull, Blunt 21 21
Fitting Problem 10 10
Detachment Of Device Component 6 6
Device Operates Differently Than Expected 6 6
Break 5 5
Difficult to Remove 4 4
Detachment of Device or Device Component 4 4
Device Slipped 3 3
Device Operational Issue 3 3
Difficult to Insert 2 2
Component Missing 2 2
Material Fragmentation 2 2
Insufficient Flow or Under Infusion 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Component Falling 2 2
Physical Resistance/Sticking 2 2
Device Markings/Labelling Problem 2 2
Material Separation 2 2
Device Dislodged or Dislocated 2 2
Device Inoperable 2 2
Air Leak 1 1
Failure To Adhere Or Bond 1 1
Ejection Problem 1 1
Collapse 1 1
Material Puncture/Hole 1 1
Device Damaged Prior to Use 1 1
Loose or Intermittent Connection 1 1
Failure to Disconnect 1 1
Device Contamination with Chemical or Other Material 1 1
Bent 1 1
Material Integrity Problem 1 1
Positioning Problem 1 1
Mechanical Problem 1 1
Disconnection 1 1
Out-Of-Box Failure 1 1
Structural Problem 1 1
Gas/Air Leak 1 1
Use of Device Problem 1 1
Unintended Ejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 87 87
No Consequences Or Impact To Patient 65 65
No Clinical Signs, Symptoms or Conditions 57 57
No Information 6 6
No Code Available 4 4
Hemorrhage/Bleeding 3 3
Endophthalmitis 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Intraocular Pressure Increased 1 1
Intraocular Pressure, Delayed, Uncontrolled 1 1
Rupture 1 1
Injury 1 1
Retinal Detachment 1 1
No Patient Involvement 1 1
Eye Injury 1 1
Internal Organ Perforation 1 1
Retinal Tear 1 1
Uveitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research, Ltd. II May-18-2016
2 Mani, Inc. - Kiyohara Facility II Apr-26-2023
3 Mani, Inc. - Kiyohara Facility II Dec-10-2020
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