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
pump, infusion, ophthalmic
Product Code
MRH
Regulation Number
880.5725
Device Class
2
Premarket Reviews
Manufacturer
Decision
GLAUKOS
SUBSTANTIALLY EQUIVALENT
1
MICROSURGICAL TECHNOLOGIES INC
SUBSTANTIALLY EQUIVALENT
1
NEW WORLD MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
SIGHT SCIENCES INC.,
SUBSTANTIALLY EQUIVALENT
1
SIGHT SCIENCES, INC.
SUBSTANTIALLY EQUIVALENT
6
MDR Year
MDR Reports
MDR Events
2017
28
28
2018
1
1
2019
2
2
2020
6
6
2021
2
2
2022
16
138
2023
31
31
2024
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
35
35
Material Fragmentation
23
23
Detachment of Device or Device Component
20
142
Detachment Of Device Component
9
9
Use of Device Problem
6
6
Improper or Incorrect Procedure or Method
5
5
Unintended Ejection
2
2
No Apparent Adverse Event
2
2
Break
1
1
Mechanical Problem
1
1
Material Twisted/Bent
1
1
Material Split, Cut or Torn
1
1
Insufficient Information
1
1
Stretched
1
1
Use of Incorrect Control/Treatment Settings
1
1
Retraction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
29
151
No Known Impact Or Consequence To Patient
19
19
Eye Injury
14
14
Intraocular Pressure Increased
13
13
Hyphema
9
9
Visual Impairment
7
7
No Consequences Or Impact To Patient
6
6
Intraocular Pressure Decreased
5
5
Hypopyon
3
3
Intraocular Pressure, Delayed, Uncontrolled
3
3
Inflammation
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Retinal Injury
2
2
Corneal Edema
2
2
Corneal Perforation
2
2
Optical Tissue, Breakdown Of
1
1
Unspecified Eye / Vision Problem
1
1
Retinal Detachment
1
1
Vitreous Hemorrhage
1
1
UGH (Uveitis Glaucoma Hyphema) Syndrome
1
1
Device Embedded In Tissue or Plaque
1
1
Uveitis
1
1
-
-