TPLC - Total Product Life Cycle

• Device: endoilluminator
• Product Code: MPA
• Regulation Number: 876.1500
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
NOVA EYE INC. (BUSINESS NAME NOVA EYE MEDICAL)
	SUBSTANTIALLY EQUIVALENT	1
OCULIGHT LTD.
	SUBSTANTIALLY EQUIVALENT	1
PEREGRINE SURGICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
SYNERGETICS
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	10	10
2015	4	4
2016	2	2
2017	2	2
2018	4	4
2022	3	3
2023	8	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	10	10
Loss of Power	5	5
Break	4	4
Unsealed Device Packaging	4	4
Delivered as Unsterile Product	3	3
Device Operates Differently Than Expected	3	3
Device Displays Incorrect Message	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Operating System Becomes Nonfunctional	2	2
Material Fragmentation	2	2
Leak/Splash	1	1
Electrical /Electronic Property Problem	1	1
Material Separation	1	1
Component Missing	1	1
Device Or Device Fragments Location Unknown	1	1
Physical Property Issue	1	1
Insufficient Information	1	1
Energy Output Problem	1	1
Device Operational Issue	1	1
Light Interference	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	13	13
No Clinical Signs, Symptoms or Conditions	8	8
No Patient Involvement	4	4
Foreign Body In Patient	3	3
No Known Impact Or Consequence To Patient	1	1
No Information	1	1
Insufficient Information	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Endophthalmitis	1	1
Eye Injury	1	1
Visual Impairment	1	1