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TPLC
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show TPLC since
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2024
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Device
forceps, ophthalmic
Product Code
HNR
Regulation Number
886.4350
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
82
82
2020
135
135
2021
63
63
2022
58
58
2023
98
98
2024
60
60
Device Problems
MDRs with this Device Problem
Events in those MDRs
Difficult to Open or Close
339
339
Adverse Event Without Identified Device or Use Problem
48
48
Break
36
36
Mechanical Jam
18
18
Physical Resistance/Sticking
16
16
Fitting Problem
5
5
Mechanical Problem
5
5
Activation Problem
4
4
Noise, Audible
3
3
Appropriate Term/Code Not Available
3
3
Difficult to Open or Remove Packaging Material
2
2
Device Fell
2
2
Defective Component
2
2
Defective Device
2
2
Positioning Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Material Fragmentation
2
2
Material Twisted/Bent
2
2
Mechanics Altered
2
2
Detachment of Device or Device Component
2
2
Dull, Blunt
1
1
Flaked
1
1
Overheating of Device
1
1
Connection Problem
1
1
Device Dislodged or Dislocated
1
1
Failure to Advance
1
1
Fracture
1
1
Device Contamination with Chemical or Other Material
1
1
Retraction Problem
1
1
Device Handling Problem
1
1
Device Damaged by Another Device
1
1
Particulates
1
1
Component Missing
1
1
Device Difficult to Setup or Prepare
1
1
Unintended Ejection
1
1
Difficult to Insert
1
1
Difficult to Remove
1
1
Separation Failure
1
1
Output Problem
1
1
Entrapment of Device
1
1
Activation, Positioning or Separation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
244
244
No Consequences Or Impact To Patient
92
92
No Known Impact Or Consequence To Patient
62
62
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
23
23
No Patient Involvement
21
21
Insufficient Information
19
19
Retinal Detachment
17
17
Retinal Tear
17
17
Hemorrhage/Bleeding
16
16
Macular Edema
4
4
Visual Impairment
4
4
Vitreous Hemorrhage
4
4
Irritability
3
3
Itching Sensation
3
3
Red Eye(s)
3
3
Foreign Body In Patient
3
3
Eye Injury
2
2
Intraocular Pressure Increased
1
1
Edema
1
1
Laceration(s)
1
1
Vitrectomy
1
1
Phototoxicity
1
1
Loss of Vision
1
1
Visual Disturbances
1
1
Tissue Damage
1
1
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Vortex Surgical Inc.
II
Feb-01-2024
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