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TPLC
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Device
device, irrigation, ocular surgery
Regulation Description
Ocular surgery irrigation device.
Product Code
KYG
Regulation Number
886.4360
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
8
8
2021
19
19
2022
20
20
2023
23
23
2024
82
90
2025
18
18
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
28
28
Adverse Event Without Identified Device or Use Problem
27
27
Sharp Edges
23
23
Material Twisted/Bent
21
21
Complete Blockage
19
19
Suction Failure
17
17
Component Missing
6
14
Decrease in Suction
6
6
Misassembled
6
14
Delivered as Unsterile Product
6
14
Obstruction of Flow
5
5
Material Fragmentation
3
3
Detachment of Device or Device Component
3
3
Suction Problem
3
3
Defective Component
2
2
Particulates
2
2
Structural Problem
2
2
Connection Problem
2
2
Loose or Intermittent Connection
2
2
Pressure Problem
1
1
Material Split, Cut or Torn
1
1
Malposition of Device
1
1
Crack
1
1
Inability to Irrigate
1
1
Material Puncture/Hole
1
1
Defective Device
1
1
Scratched Material
1
1
Material Deformation
1
1
Material Separation
1
1
Appropriate Term/Code Not Available
1
1
Dull, Blunt
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
79
87
Capsular Bag Tear
37
37
Insufficient Information
36
36
Toxic Anterior Segment Syndrome (TASS)
12
12
Uveitis
10
10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Rupture
5
5
Vitritis
4
4
Corneal Edema
4
4
Inflammation
3
3
Eye Burn
2
2
Conjunctivitis
2
2
Unspecified Infection
1
1
Hypopyon
1
1
Unspecified Eye / Vision Problem
1
1
Blurred Vision
1
1
Fibrosis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
B. Braun Medical, Inc.
II
Nov-03-2023
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