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TPLC
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show TPLC since
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2024
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Device
cannula, ophthalmic
Product Code
HMX
Regulation Number
886.4350
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
27
27
2020
27
27
2021
41
41
2022
46
46
2023
93
93
2024
83
83
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
71
71
Complete Blockage
39
39
Particulates
28
28
Fitting Problem
26
26
Obstruction of Flow
25
25
Material Separation
18
18
Adverse Event Without Identified Device or Use Problem
17
17
Break
14
14
Contamination /Decontamination Problem
9
9
Device Contamination with Chemical or Other Material
8
8
Insufficient Information
7
7
Material Opacification
6
6
Sharp Edges
5
5
Infusion or Flow Problem
5
5
Material Twisted/Bent
5
5
Material Protrusion/Extrusion
5
5
Material Frayed
4
4
Material Deformation
4
4
Activation, Positioning or Separation Problem
4
4
No Flow
4
4
Connection Problem
4
4
Fluid/Blood Leak
3
3
Activation Problem
3
3
Blocked Connection
3
3
Inadequate or Insufficient Training
3
3
Activation Failure
3
3
Partial Blockage
2
2
Unintended Ejection
2
2
Material Fragmentation
2
2
Device Dislodged or Dislocated
2
2
Defective Component
2
2
Device Fell
2
2
Inability to Irrigate
2
2
Disconnection
2
2
No Apparent Adverse Event
1
1
Appropriate Term/Code Not Available
1
1
Suction Problem
1
1
Corroded
1
1
Loose or Intermittent Connection
1
1
Device Displays Incorrect Message
1
1
Product Quality Problem
1
1
Noise, Audible
1
1
Device Handling Problem
1
1
Packaging Problem
1
1
Material Rupture
1
1
Misconnection
1
1
Device Difficult to Setup or Prepare
1
1
Backflow
1
1
Difficult to Insert
1
1
Degraded
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
164
164
Insufficient Information
31
31
Capsular Bag Tear
28
28
Foreign Body In Patient
16
16
No Consequences Or Impact To Patient
16
16
Retinal Tear
10
10
Hemorrhage/Bleeding
9
9
No Known Impact Or Consequence To Patient
9
9
Device Embedded In Tissue or Plaque
9
9
Corneal Edema
8
8
Eye Injury
8
8
Vitreous Hemorrhage
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Corneal Clouding/Hazing
4
4
Keratitis
3
3
Zonular Dehiscence
3
3
Discomfort
3
3
Needle Stick/Puncture
2
2
Prolapse
2
2
Rupture
2
2
Tissue Damage
2
2
Visual Disturbances
2
2
Endophthalmitis
2
2
Intraocular Pressure Increased
2
2
Hyphema
2
2
Failure of Implant
2
2
Retinal Injury
2
2
Eye Pain
2
2
Unspecified Tissue Injury
1
1
Swelling/ Edema
1
1
No Code Available
1
1
Inflammation
1
1
Corneal Perforation
1
1
Edema
1
1
Erosion
1
1
Cataract
1
1
Headache
1
1
Pain
1
1
Retinal Detachment
1
1
Shock
1
1
Vitreous Loss
1
1
Blurred Vision
1
1
Loss of Vision
1
1
Vitritis
1
1
Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Anodyne Surgical
II
Jun-11-2021
2
Beaver Visitec
II
Mar-27-2019
3
Beaver Visitec International, Inc.
II
Mar-14-2024
4
Dutch Ophthalmic USA, Inc.
II
Jul-19-2021
5
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
6
Vitreq Bv
II
Jan-24-2020
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