TPLC - Total Product Life Cycle

• Device: pump, infusion, ophthalmic
• Regulation Description: Infusion pump.
• 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	2
SIGHT SCIENCES INC.,
	SUBSTANTIALLY EQUIVALENT	1
SIGHT SCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2020	6	6
2021	2	2
2022	16	138
2023	31	31
2024	20	20
2025	13	13

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Fragmentation	34	34
Adverse Event Without Identified Device or Use Problem	32	32
Unintended Ejection	4	4
Use of Device Problem	4	4
Detachment of Device or Device Component	3	125
Improper or Incorrect Procedure or Method	3	3
Break	2	2
Insufficient Information	2	2
Retraction Problem	2	2
Material Split, Cut or Torn	1	1
Mechanical Problem	1	1
Off-Label Use	1	1
Stretched	1	1
Material Twisted/Bent	1	1
Lack of Effect	1	1
Use of Incorrect Control/Treatment Settings	1	1
No Apparent Adverse Event	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	44	166
Intraocular Pressure Increased	14	14
Eye Injury	14	14
Hyphema	11	11
Intraocular Pressure Decreased	5	5
Intraocular Pressure, Delayed, Uncontrolled	3	3
Visual Impairment	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Retinal Injury	2	2
Corneal Perforation	2	2
Optical Tissue, Breakdown Of	1	1
Corneal Stromal Edema	1	1
Retinal Detachment	1	1
Unspecified Eye / Vision Problem	1	1
Vitreous Hemorrhage	1	1
Corneal Edema	1	1
Blurred Vision	1	1
Hemorrhage/Bleeding	1	1
UGH (Uveitis Glaucoma Hyphema) Syndrome	1	1
Uveitis	1	1