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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 1 1 0 1 4 4 4 1 0 0 1 0 1

MDR Year MDR Reports MDR Events
2015 16 16
2016 37 37
2017 183 183
2018 34 34
2019 12 12
2020 2 2
2021 3 3
2022 2 2
2023 3 3
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 168 168
Device Dislodged or Dislocated 68 68
No Apparent Adverse Event 12 12
Insufficient Information 7 7
Improper or Incorrect Procedure or Method 6 6
Contamination 5 5
Labelling, Instructions for Use or Training Problem 5 5
Patient-Device Incompatibility 5 5
Biological Environmental Factor 4 4
Malposition of Device 4 4
Nonstandard Device 4 4
Use of Device Problem 3 3
Wrinkled 3 3
Device Operates Differently Than Expected 3 3
Patient Device Interaction Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Positioning Problem 2 2
Material Fragmentation 1 1
Environmental Particulates 1 1
Device Contamination with Chemical or Other Material 1 1
Material Opacification 1 1
Material Disintegration 1 1
Appropriate Term/Code Not Available 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Clouding/Hazing 107 107
Loss of Vision 88 88
Visual Impairment 46 46
Blurred Vision 41 41
Visual Disturbances 38 38
No Known Impact Or Consequence To Patient 38 38
Keratitis 21 21
Inflammation 18 18
Halo 15 15
Corneal Edema 15 15
Dry Eye(s) 15 15
Impaired Healing 13 13
Corneal Scar 11 11
No Consequences Or Impact To Patient 11 11
Corneal Ulcer 11 11
Corneal Abrasion 10 10
Corneal Infiltrates 8 8
Failure of Implant 7 7
Intraocular Infection 7 7
Pain 7 7
Foreign Body Sensation in Eye 6 6
Headache 4 4
Increased Sensitivity 3 3
Tissue Damage 3 3
Irritation 3 3
No Code Available 3 3
Intraocular Pressure Increased 3 3
Unspecified Infection 3 3
Unspecified Eye / Vision Problem 2 2
No Information 2 2
Eye Injury 2 2
Red Eye(s) 2 2
Vitreous Floaters 2 2
Therapeutic Effects, Unexpected 2 2
Itching Sensation 1 1
Foreign Body Reaction 1 1
Edema 1 1
Abrasion 1 1
Burning Sensation 1 1
Cataract 1 1
Depression 1 1
Viral Infection 1 1
Discomfort 1 1
Retinal Detachment 1 1
Twitching 1 1
Swelling 1 1
Corneal Decompensation 1 1
Nausea 1 1
Eye Infections 1 1
Fungal Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AcuFocus, Inc. II Mar-24-2016
2 RVO 2.0, INC I Mar-05-2019
3 Revision Optics Inc II Mar-21-2017
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