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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implant, corneal, refractive
Product CodeLQE
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
1 0 0 1 0 0

MDR Year MDR Reports MDR Events
2019 12 12
2020 2 2
2021 3 3
2022 2 2
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10 10
Nonstandard Device 4 4
Patient-Device Incompatibility 4 4
Therapeutic or Diagnostic Output Failure 2 2
Patient Device Interaction Problem 2 2
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blurred Vision 13 13
Visual Impairment 11 11
Corneal Clouding/Hazing 7 7
Headache 4 4
Failure of Implant 4 4
Dry Eye(s) 3 3
Pain 2 2
Increased Sensitivity 1 1
Swelling 1 1
Eye Injury 1 1
Foreign Body Sensation in Eye 1 1
Abdominal Pain 1 1
Corneal Scar 1 1
Unspecified Infection 1 1
Inflammation 1 1
Irritation 1 1
Itching Sensation 1 1
Nausea 1 1
Visual Disturbances 1 1
Twitching 1 1
Complaint, Ill-Defined 1 1
Patient Problem/Medical Problem 1 1
No Code Available 1 1
Eye Infections 1 1
Unspecified Eye / Vision Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 RVO 2.0, INC I Mar-05-2019
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