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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, vitreous aspiration and cutting, ac-powered
Product CodeHQE
Regulation Number 886.4150
Device Class 2


Premarket Reviews
ManufacturerDecision
VISIONCARE DEVICES, LLC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 41 41
2020 30 30
2021 32 32
2022 46 46
2023 108 108
2024 68 68

Device Problems MDRs with this Device Problem Events in those MDRs
Fitting Problem 158 158
Failure to Cut 36 36
Difficult to Insert 25 25
Suction Failure 16 16
Fluid/Blood Leak 10 10
Detachment of Device or Device Component 9 9
Defective Component 9 9
Particulates 9 9
Energy Output Problem 5 5
Material Deformation 5 5
Suction Problem 4 4
Break 4 4
Contamination /Decontamination Problem 4 4
Loose or Intermittent Connection 3 3
Display or Visual Feedback Problem 3 3
Connection Problem 3 3
Physical Resistance/Sticking 3 3
Contamination 3 3
Failure to Advance 3 3
Gas/Air Leak 3 3
Material Twisted/Bent 3 3
Ambient Noise Problem 2 2
Entrapment of Device 2 2
Noise, Audible 2 2
Inability to Irrigate 2 2
Defective Device 2 2
Component Incompatible 2 2
Power Problem 2 2
Appropriate Term/Code Not Available 2 2
Structural Problem 2 2
Delivered as Unsterile Product 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Mechanical Jam 1 1
Radiofrequency Interference (RFI) 1 1
Output below Specifications 1 1
Loss of or Failure to Bond 1 1
Temperature Problem 1 1
Inaccurate Delivery 1 1
Device Handling Problem 1 1
Decrease in Suction 1 1
Decrease in Pressure 1 1
Insufficient Flow or Under Infusion 1 1
Use of Device Problem 1 1
Failure to Power Up 1 1
Material Fragmentation 1 1
Difficult to Remove 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unsealed Device Packaging 1 1
Smoking 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 224 224
No Consequences Or Impact To Patient 30 30
Insufficient Information 22 22
No Known Impact Or Consequence To Patient 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Foreign Body In Patient 5 5
No Code Available 4 4
Hemorrhage/Bleeding 4 4
Retinal Detachment 3 3
Retinal Injury 2 2
Capsular Bag Tear 2 2
Intraocular Pressure Decreased 2 2
Retinal Tear 2 2
Device Embedded In Tissue or Plaque 2 2
Hematoma 1 1
Retinal Degeneration 1 1
Eye Burn 1 1
No Patient Involvement 1 1
Corneal Edema 1 1

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