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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoilluminator
Product CodeMPA
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
NOVA EYE INC. (BUSINESS NAME NOVA EYE MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
OCULIGHT LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 3 3
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 5 5
Break 2 2
Material Fragmentation 1 1
Energy Output Problem 1 1
Unsealed Device Packaging 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
Eye Injury 1 1
Foreign Body In Patient 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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