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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 67 67

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 226 226
Suction Failure 36 36
Suction Problem 18 18
Device Markings/Labelling Problem 7 7
Device Operates Differently Than Expected 5 5
Break 5 5
Mechanical Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Air/Gas in Device 4 4
Therapeutic or Diagnostic Output Failure 3 3
Incorrect Device Or Component Shipped 3 3
Material Twisted/Bent 3 3
Decrease in Suction 3 3
Disconnection 2 2
Complete Blockage 2 2
Contamination 2 2
Dull, Blunt 2 2
Output Problem 2 2
Physical Property Issue 2 2
Material Separation 2 2
Noise, Audible 1 1
Physical Resistance/Sticking 1 1
Mechanics Altered 1 1
Infusion or Flow Problem 1 1
Device Operational Issue 1 1
Device-Device Incompatibility 1 1
Gas/Air Leak 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1
Chemical Problem 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Failure to Calibrate 1 1
Dent in Material 1 1
Fitting Problem 1 1
Defective Component 1 1
No Device Output 1 1
Failure to Power Up 1 1
Failure to Prime 1 1
Retraction Problem 1 1
Self-Activation or Keying 1 1
Device Reprocessing Problem 1 1
Entrapment of Device 1 1
Flaked 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 219 219
No Consequences Or Impact To Patient 41 41
Insufficient Information 23 23
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 2 2
Device Embedded In Tissue or Plaque 2 2
No Code Available 2 2
Intraocular Pressure Decreased 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Capsular Bag Tear 2 2
Joint Contracture 1 1
Retinal Injury 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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