TPLC - Total Product Life Cycle

• Device: endoilluminator
• Regulation Description: Endoscope and accessories.
• Product Code: MPA
• Regulation Number: 876.1500
• Device Class: 2

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

MDR Year	MDR Reports	MDR Events
2022	3	3
2023	8	8
2024	62	62
2025	13	13
2026	14	14

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	45	45
Adverse Event Without Identified Device or Use Problem	24	24
Material Fragmentation	9	9
Retraction Problem	7	7
Appropriate Device Problem Term/Code Not Available	5	5
Mechanical Jam	4	4
Output Problem	3	3
Material Separation	3	3
Break	2	2
Energy Output Problem	2	2
Stretched	2	2
Failure to Deliver Energy	1	1
Off-Label Use	1	1
Unsealed Device Packaging	1	1
Failure to Power Up	1	1
Migration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	66	66
Eye Injury	25	25
Foreign Body In Patient	5	5
Insufficient Information	3	3
Intraocular Pressure Increased	2	2
Perforation	2	2
Toxic Anterior Segment Syndrome (TASS)	1	1
Eye Infections	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Alcon Research LLC	II	Oct-24-2025