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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device photocoagulator and accessories
Product CodeHQB
Regulation Number 886.4690
Device Class 2


Premarket Reviews
ManufacturerDecision
VITREQ B.V.
  SUBSTANTIALLY EQUIVALENT 1
VORTEX SURGICAL INC
  SUBSTANTIALLY EQUIVALENT 1
VORTEX SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 14 14
2021 1 1
2022 3 3
2023 3 3
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Deliver Energy 3 3
Gas/Air Leak 3 3
Fitting Problem 2 2
Mechanical Problem 2 2
Device Operational Issue 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Firing Problem 2 2
Break 1 1
Incomplete or Missing Packaging 1 1
Defective Device 1 1
Ejection Problem 1 1
Unintended Ejection 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Lack of Effect 1 1
Detachment of Device or Device Component 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 8 8
No Clinical Signs, Symptoms or Conditions 7 7
Pain 4 4
No Code Available 3 3
Radiation Exposure, Unintended 2 2
Awareness during Anaesthesia 2 2
Eye Burn 1 1
No Known Impact Or Consequence To Patient 1 1
Conjunctivitis 1 1
Insufficient Information 1 1
Eye Injury 1 1

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