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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)
2015 2016 2017 2018 2019 2020
1 4 4 4 1 0

MDR Year MDR Reports MDR Events
2015 16 16
2016 37 37
2017 183 183
2018 34 34
2019 12 12
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 165 165
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
Nonstandard Device 4 4
Malposition of Device 4 4
Biological Environmental Factor 4 4
Use of Device Problem 3 3
Wrinkled 3 3
Device Operates Differently Than Expected 3 3
Patient-Device Incompatibility 2 2
Positioning Problem 2 2
Device Contamination with Chemical or Other Material 1 1
Environmental Particulates 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Opacification 1 1
Material Disintegration 1 1
Material Fragmentation 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Clouding/Hazing 104 104
Loss of Vision 88 88
Visual Impairment 43 43
No Known Impact Or Consequence To Patient 38 38
Visual Disturbances 37 37
Blurred Vision 34 34
Keratitis 21 21
Inflammation 18 18
Corneal Edema 15 15
Halo 15 15
Dry Eye(s) 14 14
Impaired Healing 13 13
Corneal Ulcer 11 11
No Consequences Or Impact To Patient 11 11
Corneal Scar 10 10
Corneal Abrasion 9 9
Corneal Infiltrates 8 8
Pain 7 7
Intraocular Infection 7 7
Foreign Body Sensation in Eye 6 6
Intraocular Pressure Increased 3 3
Tissue Damage 3 3
No Code Available 3 3
Irritation 3 3
Increased Sensitivity 2 2
Vitreous Floaters 2 2
Failure of Implant 2 2
Therapeutic Effects, Unexpected 2 2
No Information 2 2
Headache 2 2
Unspecified Infection 2 2
Red Eye(s) 2 2
Retinal Detachment 1 1
Itching Sensation 1 1
Abdominal Pain 1 1
Bacterial Infection 1 1
Edema 1 1
Eye Injury 1 1
Foreign Body Reaction 1 1
Patient Problem/Medical Problem 1 1
Burning Sensation 1 1
Twitching 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Depression 1 1
Herpes 1 1
High Blood Pressure/ Hypertension 1 1
Corneal Decompensation 1 1
Abrasion 1 1
Cataract 1 1
Swelling 1 1
Viral Infection 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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