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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)
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
1 4 4 4 1 0 0 1 0 0

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

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
Patient-Device Incompatibility 5 5
Labelling, Instructions for Use or Training Problem 5 5
Nonstandard Device 4 4
Malposition of Device 4 4
Biological Environmental Factor 4 4
Device Operates Differently Than Expected 3 3
Wrinkled 3 3
Use of Device Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Patient Device Interaction Problem 2 2
Positioning Problem 2 2
Material Opacification 1 1
Material Fragmentation 1 1
Environmental Particulates 1 1
Device Contamination with Chemical or Other Material 1 1
Appropriate Term/Code Not Available 1 1
Material Disintegration 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
Corneal Edema 15 15
Halo 15 15
Dry Eye(s) 15 15
Impaired Healing 13 13
Corneal Ulcer 11 11
No Consequences Or Impact To Patient 11 11
Corneal Scar 11 11
Corneal Abrasion 9 9
Corneal Infiltrates 8 8
Pain 7 7
Intraocular Infection 7 7
Foreign Body Sensation in Eye 6 6
Failure of Implant 6 6
Headache 4 4
Unspecified Infection 3 3
Increased Sensitivity 3 3
Intraocular Pressure Increased 3 3
Irritation 3 3
No Code Available 3 3
Tissue Damage 3 3
Red Eye(s) 2 2
Vitreous Floaters 2 2
Therapeutic Effects, Unexpected 2 2
Eye Injury 2 2
No Information 2 2
Edema 1 1
Bacterial Infection 1 1
Patient Problem/Medical Problem 1 1
Viral Infection 1 1
High Blood Pressure/ Hypertension 1 1
Corneal Decompensation 1 1
Eye Infections 1 1
Fungal Infection 1 1
Retinal Detachment 1 1
Discomfort 1 1
Depression 1 1
Itching Sensation 1 1
Burning Sensation 1 1
Complaint, Ill-Defined 1 1
Unspecified Eye / Vision Problem 1 1
Cataract 1 1
Herpes 1 1
Abrasion 1 1
Swelling 1 1
Twitching 1 1
Nausea 1 1
Abdominal Pain 1 1
Foreign Body Reaction 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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