Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 Back to Search Results
Device pump, infusion, ophthalmic
Product CodeMRH
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
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
Insufficient Information 1 1
Material Twisted/Bent 1 1
Material Split, Cut or Torn 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
Retinal Detachment 1 1
Unspecified Eye / Vision Problem 1 1
Vitreous Hemorrhage 1 1
UGH (Uveitis Glaucoma Hyphema) Syndrome 1 1
Uveitis 1 1
Device Embedded In Tissue or Plaque 1 1

-
-