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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
Product CodeMLZ
Regulation Number 886.4150
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCON RESEARCH, LTD.
  SUBSTANTIALLY EQUIVALENT 1
VISTA OPHTHALMICS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 10 10
2018 8 8
2019 6 6
2020 54 54
2021 40 40
2022 40 40
2023 92 92
2024 123 123

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 259 259
Suction Failure 52 52
Suction Problem 27 27
Break 10 10
Air/Gas in Device 8 8
Device Markings/Labelling Problem 7 7
Device Operates Differently Than Expected 5 5
Contamination 4 4
Mechanical Problem 4 4
Material Twisted/Bent 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Material Separation 3 3
Complete Blockage 3 3
Therapeutic or Diagnostic Output Failure 3 3
Incorrect Device Or Component Shipped 3 3
Decrease in Suction 3 3
Disconnection 2 2
Physical Property Issue 2 2
Gas/Air Leak 2 2
Output Problem 2 2
Loose or Intermittent Connection 2 2
Dull, Blunt 2 2
Failure to Prime 1 1
Retraction Problem 1 1
Detachment of Device or Device Component 1 1
Entrapment of Device 1 1
Device Operational Issue 1 1
Physical Resistance/Sticking 1 1
Infusion or Flow Problem 1 1
Mechanics Altered 1 1
No Device Output 1 1
Noise, Audible 1 1
Device Displays Incorrect Message 1 1
Flaked 1 1
Self-Activation or Keying 1 1
Device Reprocessing Problem 1 1
Failure to Calibrate 1 1
Failure to Power Up 1 1
Dent in Material 1 1
Contamination /Decontamination Problem 1 1
Defective Component 1 1
Defective Device 1 1
Chemical Problem 1 1
Leak/Splash 1 1
Fitting Problem 1 1
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 271 271
No Consequences Or Impact To Patient 41 41
Insufficient Information 26 26
No Known Impact Or Consequence To Patient 16 16
No Patient Involvement 7 7
Intraocular Pressure Increased 5 5
Eye Injury 4 4
Vitreous Hemorrhage 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Code Available 2 2
Capsular Bag Tear 2 2
Intraocular Pressure Decreased 2 2
Device Embedded In Tissue or Plaque 2 2
Retinal Injury 1 1
Joint Contracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical Optics Inc. (AMO) II May-16-2017
2 Johnson & Johnson Surgical Vision Inc II Jun-28-2019
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