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TPLC
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show TPLC since
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2024
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Device
vitrectomy, instrument cutter
Product Code
MLZ
Regulation Number
886.4150
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
Mechanical Problem
4
4
Material Twisted/Bent
4
4
Contamination
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Incorrect Device Or Component Shipped
3
3
Decrease in Suction
3
3
Material Separation
3
3
Therapeutic or Diagnostic Output Failure
3
3
Complete Blockage
3
3
Output Problem
2
2
Loose or Intermittent Connection
2
2
Gas/Air Leak
2
2
Dull, Blunt
2
2
Disconnection
2
2
Physical Property Issue
2
2
Flaked
1
1
Device Displays Incorrect Message
1
1
Contamination /Decontamination Problem
1
1
Failure to Prime
1
1
Detachment of Device or Device Component
1
1
Retraction Problem
1
1
Defective Component
1
1
Defective Device
1
1
Fitting Problem
1
1
Leak/Splash
1
1
Device-Device Incompatibility
1
1
Chemical Problem
1
1
Noise, Audible
1
1
No Device Output
1
1
Self-Activation or Keying
1
1
Device Reprocessing Problem
1
1
Failure to Calibrate
1
1
Mechanics Altered
1
1
Infusion or Flow Problem
1
1
Dent in Material
1
1
Failure to Power Up
1
1
Entrapment of Device
1
1
Physical Resistance/Sticking
1
1
Device Operational Issue
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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