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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 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Fitting Problem 136 136
Difficult to Insert 25 25
Failure to Cut 22 22
Fluid/Blood Leak 10 10
Particulates 9 9
Detachment of Device or Device Component 9 9
Suction Failure 9 9
Defective Component 7 7
Material Deformation 5 5
Contamination /Decontamination Problem 4 4
Energy Output Problem 4 4
Break 3 3
Display or Visual Feedback Problem 3 3
Failure to Advance 3 3
Connection Problem 3 3
Physical Resistance/Sticking 3 3
Gas/Air Leak 3 3
Appropriate Term/Code Not Available 2 2
Noise, Audible 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Power Problem 2 2
Material Twisted/Bent 2 2
Structural Problem 2 2
Suction Problem 2 2
Entrapment of Device 2 2
Component Incompatible 2 2
Inability to Irrigate 2 2
Loose or Intermittent Connection 2 2
Delivered as Unsterile Product 2 2
Unsealed Device Packaging 1 1
Material Fragmentation 1 1
Contamination 1 1
Crack 1 1
Decrease in Suction 1 1
Disconnection 1 1
Filling Problem 1 1
Accessory Incompatible 1 1
Loss of or Failure to Bond 1 1
Insufficient Flow or Under Infusion 1 1
Device Damaged Prior to Use 1 1
Inaccurate Delivery 1 1
Failure to Power Up 1 1
Decrease in Pressure 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Smoking 1 1
Use of Device Problem 1 1
Mechanical Jam 1 1
Device-Device Incompatibility 1 1
Device Contamination with Chemical or Other Material 1 1
Activation, Positioning or Separation Problem 1 1
Defective Device 1 1
Failure to Fire 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 184 184
No Consequences Or Impact To Patient 30 30
No Known Impact Or Consequence To Patient 21 21
Insufficient Information 12 12
Foreign Body In Patient 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Code Available 4 4
Hemorrhage/Bleeding 4 4
Retinal Detachment 2 2
Retinal Injury 2 2
Intraocular Pressure Decreased 2 2
Device Embedded In Tissue or Plaque 2 2
Capsular Bag Tear 2 2
No Patient Involvement 1 1
Retinal Degeneration 1 1
Retinal Tear 1 1
Eye Burn 1 1
Corneal Edema 1 1
Hematoma 1 1

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