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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 91 91

Device Problems MDRs with this Device Problem Events in those MDRs
Fitting Problem 164 164
Failure to Cut 40 40
Difficult to Insert 27 27
Suction Failure 20 20
Fluid/Blood Leak 10 10
Detachment of Device or Device Component 9 9
Particulates 9 9
Defective Component 9 9
Energy Output Problem 6 6
Suction Problem 5 5
Material Deformation 5 5
Break 4 4
Material Twisted/Bent 4 4
Gas/Air Leak 4 4
Contamination /Decontamination Problem 4 4
Loose or Intermittent Connection 3 3
Display or Visual Feedback Problem 3 3
Connection Problem 3 3
Failure to Advance 3 3
Contamination 3 3
Physical Resistance/Sticking 3 3
Noise, Audible 2 2
Defective Device 2 2
Inability to Irrigate 2 2
Component Incompatible 2 2
Entrapment of Device 2 2
Structural Problem 2 2
Appropriate Term/Code Not Available 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Delivered as Unsterile Product 2 2
Power Problem 2 2
Failure to Fire 2 2
Ambient Noise Problem 2 2
Temperature Problem 1 1
Output below Specifications 1 1
Radiofrequency Interference (RFI) 1 1
Disconnection 1 1
Loss of or Failure to Bond 1 1
Mechanical Jam 1 1
Failure to Deliver Energy 1 1
Activation, Positioning or Separation Problem 1 1
Device-Device Incompatibility 1 1
Inaccurate Delivery 1 1
Device Contamination with Chemical or Other Material 1 1
Accessory Incompatible 1 1
Inadequacy of Device Shape and/or Size 1 1
Retraction Problem 1 1
Device Handling Problem 1 1
Crack 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 245 245
No Consequences Or Impact To Patient 30 30
Insufficient Information 24 24
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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