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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device implant, corneal, refractive
Product CodeLQE
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
4 1 0 0 1 0

MDR Year MDR Reports MDR Events
2018 34 34
2019 12 12
2020 2 2
2021 3 3
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 32 32
Device Dislodged or Dislocated 7 7
Patient-Device Incompatibility 4 4
Nonstandard Device 4 4
Use of Device Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Insufficient Information 1 1
Patient Device Interaction Problem 1 1
Material Disintegration 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 24 24
Corneal Clouding/Hazing 21 21
Blurred Vision 12 12
Inflammation 5 5
Headache 4 4
Visual Disturbances 4 4
No Known Impact Or Consequence To Patient 4 4
Loss of Vision 3 3
Failure of Implant 3 3
Dry Eye(s) 3 3
Corneal Scar 2 2
Pain 2 2
Retinal Detachment 1 1
Increased Sensitivity 1 1
Swelling 1 1
Tissue Damage 1 1
Herpes 1 1
Abdominal Pain 1 1
Eye Injury 1 1
Foreign Body Sensation in Eye 1 1
Irritation 1 1
Itching Sensation 1 1
Keratitis 1 1
Nausea 1 1
No Code Available 1 1
Eye Infections 1 1
Unspecified Eye / Vision Problem 1 1
Twitching 1 1
No Consequences Or Impact To Patient 1 1
Halo 1 1
Complaint, Ill-Defined 1 1
Impaired Healing 1 1
Patient Problem/Medical Problem 1 1

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