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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device plug, punctum
Product CodeLZU
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
BIO OPTICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OASIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VISANT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 5 5
2024 1 1
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Activation Failure 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 4 4
Dry Eye(s) 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Discomfort 2 2
Red Eye(s) 1 1
Swelling/ Edema 1 1
Blurred Vision 1 1
Corneal Scar 1 1
Increased Sensitivity 1 1

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