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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
2020 30 30
2021 32 32
2022 46 46
2023 108 108
2024 104 104

Device Problems MDRs with this Device Problem Events in those MDRs
Fitting Problem 156 156
Failure to Cut 38 38
Suction Failure 21 21
Difficult to Insert 13 13
Break 11 11
Fluid/Blood Leak 10 10
Defective Component 9 9
Suction Problem 8 8
Particulates 8 8
Detachment of Device or Device Component 6 6
Energy Output Problem 5 5
Contamination /Decontamination Problem 4 4
Gas/Air Leak 4 4
Material Twisted/Bent 4 4
Material Deformation 4 4
Physical Resistance/Sticking 3 3
Loose or Intermittent Connection 3 3
Display or Visual Feedback Problem 3 3
Complete Blockage 3 3
Connection Problem 3 3
Contamination 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Inability to Irrigate 2 2
Defective Device 2 2
Appropriate Term/Code Not Available 2 2
Failure to Advance 2 2
Ambient Noise Problem 2 2
Failure to Fire 2 2
Temperature Problem 1 1
Output below Specifications 1 1
Radiofrequency Interference (RFI) 1 1
Mechanical Jam 1 1
Component Incompatible 1 1
Device Contamination with Chemical or Other Material 1 1
Retraction Problem 1 1
Device Handling Problem 1 1
Delivered as Unsterile Product 1 1
Insufficient Flow or Under Infusion 1 1
Decrease in Pressure 1 1
Decrease in Suction 1 1
Use of Device Problem 1 1
Material Fragmentation 1 1
Difficult to Remove 1 1
Smoking 1 1
Device Fell 1 1
Filling Problem 1 1
Device Damaged Prior to Use 1 1
Crack 1 1
Accessory Incompatible 1 1
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 247 247
Insufficient Information 33 33
No Consequences Or Impact To Patient 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Foreign Body In Patient 5 5
No Known Impact Or Consequence To Patient 4 4
Hemorrhage/Bleeding 4 4
Retinal Detachment 3 3
Retinal Tear 3 3
No Code Available 2 2
Inflammation 2 2
Capsular Bag Tear 2 2
Eye Infections 2 2
Intraocular Pressure Decreased 2 2
Intraocular Pressure Increased 1 1
Endophthalmitis 1 1
Transmissible Spongiform Encephalopathy(TSE) 1 1
Hematoma 1 1
Retinal Degeneration 1 1
Eye Burn 1 1
No Patient Involvement 1 1
Laceration(s) 1 1
Eye Injury 1 1
Blurred Vision 1 1
Eye Pain 1 1

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