TPLC - Total Product Life Cycle

• 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	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	34	34
Material Fragmentation	20	20
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
No Apparent Adverse Event	2	2
Material Split, Cut or Torn	1	1
Use of Incorrect Control/Treatment Settings	1	1
Mechanical Problem	1	1
Break	1	1
Insufficient Information	1	1
Stretched	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	24	146
No Known Impact Or Consequence To Patient	19	19
Eye Injury	14	14
Intraocular Pressure Increased	11	11
Hyphema	8	8
Visual Impairment	7	7
No Consequences Or Impact To Patient	6	6
Intraocular Pressure Decreased	5	5
Hypopyon	3	3
Inflammation	3	3
Intraocular Pressure, Delayed, Uncontrolled	3	3
Corneal Edema	2	2
Corneal Perforation	2	2
Retinal Injury	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Optical Tissue, Breakdown Of	1	1
Uveitis	1	1
Vitreous Hemorrhage	1	1
UGH (Uveitis Glaucoma Hyphema) Syndrome	1	1
Unspecified Eye / Vision Problem	1	1
Device Embedded In Tissue or Plaque	1	1
Retinal Detachment	1	1