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TPLC
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Device
instrument, vitreous aspiration and cutting, ac-powered
Regulation Description
Vitreous aspiration and cutting instrument.
Product Code
HQE
Regulation Number
886.4150
Device Class
2
Premarket Reviews
Manufacturer
Decision
VISIONCARE DEVICES, LLC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
30
30
2021
32
32
2022
46
46
2023
108
108
2024
105
105
2025
158
158
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fitting Problem
159
159
Adverse Event Without Identified Device or Use Problem
135
135
Failure to Cut
43
43
Suction Failure
31
31
Difficult to Insert
16
16
Break
11
11
Fluid/Blood Leak
10
10
Suction Problem
10
10
Defective Component
9
9
Particulates
8
8
Detachment of Device or Device Component
6
6
Energy Output Problem
5
5
Gas/Air Leak
5
5
Complete Blockage
4
4
Contamination /Decontamination Problem
4
4
Material Twisted/Bent
4
4
Material Deformation
4
4
Physical Resistance/Sticking
3
3
Loose or Intermittent Connection
3
3
Display or Visual Feedback Problem
3
3
Connection Problem
3
3
Contamination
3
3
Ambient Noise Problem
3
3
Inability to Irrigate
2
2
Defective Device
2
2
Appropriate Term/Code Not Available
2
2
Failure to Advance
2
2
Failure to Fire
2
2
Temperature Problem
1
1
Output below Specifications
1
1
Radiofrequency Interference (RFI)
1
1
Mechanical Jam
1
1
Component Incompatible
1
1
Device Contamination with Chemical or Other Material
1
1
Retraction Problem
1
1
Device Handling Problem
1
1
Delivered as Unsterile Product
1
1
Insufficient Flow or Under Infusion
1
1
Decrease in Pressure
1
1
Decrease in Suction
1
1
Improper Flow or Infusion
1
1
Use of Device Problem
1
1
Material Fragmentation
1
1
Difficult to Remove
1
1
Smoking
1
1
Device Fell
1
1
Filling Problem
1
1
Device Damaged Prior to Use
1
1
Crack
1
1
Accessory Incompatible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
269
269
Eye Infections
44
44
Insufficient Information
38
38
Transmissible Spongiform Encephalopathy(TSE)
33
33
Endophthalmitis
26
26
Retinal Tear
23
23
No Consequences Or Impact To Patient
12
12
Laceration(s)
9
9
Phototoxicity
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Inflammation
5
5
Foreign Body In Patient
5
5
Loss of Vision
5
5
No Known Impact Or Consequence To Patient
4
4
Hemorrhage/Bleeding
4
4
Intraocular Pressure Increased
3
3
Retinal Detachment
3
3
Blurred Vision
3
3
No Code Available
2
2
Eye Burn
2
2
Capsular Bag Tear
2
2
Intraocular Pressure Decreased
2
2
Iritis
1
1
Hematoma
1
1
Retinal Degeneration
1
1
No Patient Involvement
1
1
Eye Injury
1
1
Eye Pain
1
1
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