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TPLC
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Device
vitrectomy, instrument cutter
Regulation Description
Vitreous aspiration and cutting instrument.
Product Code
MLZ
Regulation Number
886.4150
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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