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TPLC
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show TPLC since
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2024
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Device
device, irrigation, ocular surgery
Product Code
KYG
Regulation Number
886.4360
Device Class
1
MDR Year
MDR Reports
MDR Events
2016
14
14
2017
10
10
2018
10
10
2019
13
13
2020
8
8
2021
19
19
2022
20
20
2023
23
23
2024
48
56
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
32
32
Break
28
28
Material Twisted/Bent
16
16
Sharp Edges
10
10
Complete Blockage
9
9
Suction Failure
9
9
Misassembled
6
14
Delivered as Unsterile Product
6
14
Component Missing
6
14
Scratched Material
6
6
Device Operates Differently Than Expected
4
4
Material Integrity Problem
4
4
Defective Device
4
4
Loose or Intermittent Connection
3
3
Structural Problem
3
3
Material Fragmentation
3
3
Suction Problem
3
3
Insufficient Information
3
3
Device Slipped
2
2
Disconnection
2
2
Crack
2
2
Defective Component
2
2
Connection Problem
2
2
Material Too Rigid or Stiff
2
2
Appropriate Term/Code Not Available
2
2
Obstruction of Flow
2
2
Decrease in Suction
2
2
Particulates
2
2
Material Deformation
2
2
Collapse
2
2
Inability to Irrigate
2
2
Material Split, Cut or Torn
1
1
Pressure Problem
1
1
Malposition of Device
1
1
Torn Material
1
1
Leak/Splash
1
1
Noise, Audible
1
1
Dull, Blunt
1
1
Device Contamination with Chemical or Other Material
1
1
Aspiration Issue
1
1
Inaccurate Flow Rate
1
1
Detachment of Device or Device Component
1
1
Material Separation
1
1
Infusion or Flow Problem
1
1
Material Puncture/Hole
1
1
Device Unsafe to Use in Environment
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
58
66
Capsular Bag Tear
38
38
Insufficient Information
19
19
No Known Impact Or Consequence To Patient
16
16
Toxic Anterior Segment Syndrome (TASS)
12
12
Uveitis
10
10
Rupture
9
9
No Consequences Or Impact To Patient
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Vitritis
4
4
Corneal Edema
4
4
Inflammation
3
3
No Code Available
2
2
Eye Burn
2
2
Conjunctivitis
2
2
Unspecified Infection
1
1
Hypopyon
1
1
No Information
1
1
No Patient Involvement
1
1
Blurred Vision
1
1
Fibrosis
1
1
Excessive Tear Production
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
B. Braun Medical, Inc.
II
Nov-03-2023
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