Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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
Scratched Material
6
6
Component Missing
6
14
Misassembled
6
14
Delivered as Unsterile Product
6
14
Device Operates Differently Than Expected
4
4
Material Integrity Problem
4
4
Defective Device
4
4
Material Fragmentation
3
3
Loose or Intermittent Connection
3
3
Suction Problem
3
3
Structural Problem
3
3
Insufficient Information
3
3
Connection Problem
2
2
Appropriate Term/Code Not Available
2
2
Defective Component
2
2
Inability to Irrigate
2
2
Collapse
2
2
Crack
2
2
Device Slipped
2
2
Disconnection
2
2
Material Deformation
2
2
Particulates
2
2
Decrease in Suction
2
2
Material Too Rigid or Stiff
2
2
Obstruction of Flow
2
2
Material Split, Cut or Torn
1
1
Leak/Splash
1
1
Torn Material
1
1
Pressure Problem
1
1
Material Puncture/Hole
1
1
Device Unsafe to Use in Environment
1
1
Inaccurate Flow Rate
1
1
Infusion or Flow Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Detachment of Device or Device Component
1
1
Material Separation
1
1
Aspiration Issue
1
1
Malposition of Device
1
1
Noise, Audible
1
1
Dull, Blunt
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
-
-