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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)
2017 2018 2019 2020 2021 2022
4 4 1 0 0 1

MDR Year MDR Reports MDR Events
2017 183 183
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 138 138
Device Dislodged or Dislocated 64 64
Contamination 5 5
Labelling, Instructions for Use or Training Problem 5 5
Patient-Device Incompatibility 5 5
Biological Environmental Factor 4 4
Nonstandard Device 4 4
No Apparent Adverse Event 4 4
Use of Device Problem 3 3
Wrinkled 2 2
Malposition of Device 2 2
Device Operates Differently Than Expected 2 2
Insufficient Information 2 2
Positioning Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Environmental Particulates 1 1
Device Contamination with Chemical or Other Material 1 1
Patient Device Interaction Problem 1 1
Unexpected Therapeutic Results 1 1
Material Disintegration 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Clouding/Hazing 91 91
Loss of Vision 80 80
No Known Impact Or Consequence To Patient 38 38
Visual Disturbances 36 36
Visual Impairment 35 35
Blurred Vision 30 30
Halo 15 15
Dry Eye(s) 14 14
Keratitis 11 11
No Consequences Or Impact To Patient 11 11
Inflammation 10 10
Corneal Edema 9 9
Corneal Scar 9 9
Corneal Ulcer 6 6
Corneal Abrasion 4 4
Foreign Body Sensation in Eye 4 4
Headache 4 4
Pain 4 4
Increased Sensitivity 3 3
Irritation 3 3
Tissue Damage 3 3
Failure of Implant 3 3
Impaired Healing 3 3
No Information 2 2
No Code Available 2 2
Intraocular Pressure Increased 2 2
Vitreous Floaters 2 2
Therapeutic Effects, Unexpected 2 2
Corneal Infiltrates 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Itching Sensation 1 1
Nausea 1 1
Swelling 1 1
Retinal Detachment 1 1
Edema 1 1
Eye Injury 1 1
Abdominal Pain 1 1
Bacterial Infection 1 1
Cataract 1 1
Herpes 1 1
High Blood Pressure/ Hypertension 1 1
Eye Infections 1 1
Unspecified Eye / Vision Problem 1 1
Fungal Infection 1 1
Patient Problem/Medical Problem 1 1
Twitching 1 1

Recalls
Manufacturer Recall Class Date Posted
1 RVO 2.0, INC I Mar-05-2019
2 Revision Optics Inc II Mar-21-2017
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