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TPLC
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show TPLC since
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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
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