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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
VISTA OPHTHALMICS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 54 54
2021 40 40
2022 40 40
2023 91 91
2024 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 200 200
Suction Failure 24 24
Suction Problem 14 14
Break 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Air/Gas in Device 4 4
Mechanical Problem 4 4
Decrease in Suction 3 3
Therapeutic or Diagnostic Output Failure 3 3
Output Problem 2 2
Contamination 2 2
Disconnection 2 2
Entrapment of Device 1 1
Loose or Intermittent Connection 1 1
No Device Output 1 1
Failure to Power Up 1 1
Failure to Prime 1 1
Retraction Problem 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
Device-Device Incompatibility 1 1
Gas/Air Leak 1 1
Infusion or Flow Problem 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Fitting Problem 1 1
Defective Component 1 1
Dull, Blunt 1 1
Failure to Calibrate 1 1
Dent in Material 1 1
Noise, Audible 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 182 182
No Consequences Or Impact To Patient 36 36
Insufficient Information 17 17
No Known Impact Or Consequence To Patient 13 13
Intraocular Pressure Increased 4 4
Eye Injury 3 3
Intraocular Pressure Decreased 2 2
Capsular Bag Tear 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Vitreous Hemorrhage 2 2
Retinal Injury 1 1
Joint Contracture 1 1
Device Embedded In Tissue or Plaque 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Johnson & Johnson Surgical Vision Inc II Jun-28-2019
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