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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pump, infusion, ophthalmic
Regulation Description Infusion pump.
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 2
SIGHT SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 2 2
2022 16 138
2023 31 31
2024 20 20
2025 14 14
2026 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 38 38
Adverse Event Without Identified Device or Use Problem 33 33
Unintended Ejection 4 4
Use of Device Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Detachment of Device or Device Component 2 124
Lack of Effect 1 1
Off-Label Use 1 1
Material Twisted/Bent 1 1
Mechanical Problem 1 1
Retraction Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Insufficient Device Problem Information 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 47 169
Eye Injury 15 15
Intraocular Pressure Increased 14 14
Hyphema 10 10
Intraocular Pressure Decreased 7 7
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 4 4
Visual Impairment 2 2
Corneal Perforation 2 2
Retinal Detachment 1 1
Corneal Edema 1 1
Blurred Vision 1 1
Corneal Stromal Edema 1 1
UGH (Uveitis Glaucoma Hyphema) Syndrome 1 1
Unspecified Eye / Vision Problem 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Uveitis 1 1

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