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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device vitrectomy, instrument cutter
Regulation Description Vitreous aspiration and cutting instrument.
Product CodeMLZ
Regulation Number 886.4150
Device Class 2


Premarket Reviews
ManufacturerDecision
VISTA OPHTHALMICS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 54 54
2021 40 40
2022 40 40
2023 92 92
2024 189 189
2025 89 89

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 372 372
Suction Failure 79 79
Suction Problem 39 39
Break 13 13
Air/Gas in Device 11 11
Material Twisted/Bent 7 7
Decrease in Suction 5 5
Mechanical Problem 4 4
Complete Blockage 4 4
Contamination 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Dull, Blunt 4 4
Disconnection 3 3
Therapeutic or Diagnostic Output Failure 3 3
Output Problem 2 2
Defective Device 2 2
Material Separation 2 2
Detachment of Device or Device Component 2 2
Leak/Splash 1 1
Fitting Problem 1 1
Chemical Problem 1 1
Entrapment of Device 1 1
Crack 1 1
Device Markings/Labelling Problem 1 1
Defective Component 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Power Up 1 1
Device Difficult to Setup or Prepare 1 1
Gas/Air Leak 1 1
Infusion or Flow Problem 1 1
Mechanics Altered 1 1
Failure to Prime 1 1
Retraction Problem 1 1
Failure to Calibrate 1 1
Loose or Intermittent Connection 1 1
Device Displays Incorrect Message 1 1
No Device Output 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 415 415
No Consequences Or Impact To Patient 33 33
Insufficient Information 32 32
No Known Impact Or Consequence To Patient 10 10
Intraocular Pressure Increased 4 4
Capsular Bag Tear 4 4
Eye Injury 4 4
Vitreous Hemorrhage 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Foreign Body In Patient 2 2
Intraocular Pressure Decreased 2 2
No Code Available 1 1
Retinal Injury 1 1
Joint Contracture 1 1
Device Embedded In Tissue or Plaque 1 1

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