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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoilluminator
Regulation Description Endoscope and accessories.
Product CodeMPA
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVA EYE INC. (BUSINESS NAME NOVA EYE MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
OCULIGHT , LTD.
  SUBSTANTIALLY EQUIVALENT 1
PEREGRINE SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 3 3
2023 8 8
2024 62 62
2025 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 45 45
Adverse Event Without Identified Device or Use Problem 12 12
Material Fragmentation 9 9
Retraction Problem 7 7
Appropriate Term/Code Not Available 5 5
Mechanical Jam 4 4
Material Separation 3 3
Break 2 2
Output Problem 2 2
Energy Output Problem 2 2
Stretched 2 2
Failure to Deliver Energy 1 1
Off-Label Use 1 1
Unsealed Device Packaging 1 1
Failure to Power Up 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 64 64
Eye Injury 15 15
Foreign Body In Patient 5 5
Intraocular Pressure Increased 2 2
Perforation 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research LLC II Oct-24-2025
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