TPLC - Total Product Life Cycle

• Device: plug, punctum
• Product Code: LZU
• Device Class: Unclassified

Premarket Reviews
Manufacturer	Decision
ALPHAMED INC
	SUBSTANTIALLY EQUIVALENT	1
KRISHNA IMPORTS INC DBA STEPHENS INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	1
LACRIMEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
OASIS MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
OASIS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ODYSSEY MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PARAGON BIOTECK, INC.
	SUBSTANTIALLY EQUIVALENT	1
RIVERPOINT MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
VISANT MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	10	10
2015	1	1
2017	3	3
2018	2	2
2020	1	1
2023	5	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Migration or Expulsion of Device	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Insufficient Information	4	4
Activation Failure	1	1
No Apparent Adverse Event	1	1
Break	1	1
Device Expiration Issue	1	1
Incorrect Measurement	1	1
Delivered as Unsterile Product	1	1
Patient-Device Incompatibility	1	1
Material Protrusion/Extrusion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Inflammation	5	5
Discharge	3	3
Unspecified Infection	3	3
No Known Impact Or Consequence To Patient	3	3
Insufficient Information	2	2
Discomfort	2	2
Irritation	2	2
Pain	2	2
Dry Eye(s)	2	2
Granuloma	2	2
Abscess	1	1
Foreign Body Sensation in Eye	1	1
Red Eye(s)	1	1
Excessive Tear Production	1	1
No Clinical Signs, Symptoms or Conditions	1	1
No Code Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Lacrimedics Inc	II	Mar-01-2022
2	Lacrimedics Inc	III	Feb-10-2015