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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device plug, punctum
Product CodeLZU
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ALPHAMED INC
  SUBSTANTIALLY EQUIVALENT 1
LACRIMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OASIS MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
OASIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 3 3
2018 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Break 1 1
Device Expiration Issue 1 1
Incorrect Measurement 1 1
Delivered as Unsterile Product 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Code Available 1 1
Abscess 1 1
Unspecified Infection 1 1
Pain 1 1
Discharge 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Lacrimedics Inc II Mar-01-2022
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