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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
Regulation Description Vitreous aspiration and cutting instrument.
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 105 105
2025 158 158

Device Problems MDRs with this Device Problem Events in those MDRs
Fitting Problem 159 159
Adverse Event Without Identified Device or Use Problem 135 135
Failure to Cut 43 43
Suction Failure 31 31
Difficult to Insert 16 16
Break 11 11
Fluid/Blood Leak 10 10
Suction Problem 10 10
Defective Component 9 9
Particulates 8 8
Detachment of Device or Device Component 6 6
Energy Output Problem 5 5
Gas/Air Leak 5 5
Complete Blockage 4 4
Contamination /Decontamination Problem 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
Connection Problem 3 3
Contamination 3 3
Ambient Noise Problem 3 3
Inability to Irrigate 2 2
Defective Device 2 2
Appropriate Term/Code Not Available 2 2
Failure to Advance 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
Improper Flow or Infusion 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 269 269
Eye Infections 44 44
Insufficient Information 38 38
Transmissible Spongiform Encephalopathy(TSE) 33 33
Endophthalmitis 26 26
Retinal Tear 23 23
No Consequences Or Impact To Patient 12 12
Laceration(s) 9 9
Phototoxicity 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Inflammation 5 5
Foreign Body In Patient 5 5
Loss of Vision 5 5
No Known Impact Or Consequence To Patient 4 4
Hemorrhage/Bleeding 4 4
Intraocular Pressure Increased 3 3
Retinal Detachment 3 3
Blurred Vision 3 3
No Code Available 2 2
Eye Burn 2 2
Capsular Bag Tear 2 2
Intraocular Pressure Decreased 2 2
Iritis 1 1
Hematoma 1 1
Retinal Degeneration 1 1
No Patient Involvement 1 1
Eye Injury 1 1
Eye Pain 1 1

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