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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lens, intraocular, phakic
Product CodeMTA
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
3 5 4 2 1 2 2 0 5 3 6 1 1 4 0 1

MDR Year MDR Reports MDR Events
2014 781 781
2015 1279 1279
2016 1456 1456
2017 1796 1796
2018 1778 1778
2019 1236 1236
2020 1440 1440
2021 2063 2063
2022 1917 1917
2023 2087 2087
2024 527 527

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequacy of Device Shape and/or Size 10206 10206
Off-Label Use 2557 2557
Appropriate Term/Code Not Available 2465 2465
No Apparent Adverse Event 1509 1509
Adverse Event Without Identified Device or Use Problem 1169 1169
Device Operates Differently Than Expected 1107 1107
Misfocusing 992 992
Device Dislodged or Dislocated 474 474
Unintended Movement 406 406
Optical Problem 342 342
Torn Material 252 252
Insufficient Information 234 234
Patient-Device Incompatibility 167 167
Break 87 87
Improper or Incorrect Procedure or Method 68 68
Positioning Failure 51 51
Device Contamination with Chemical or Other Material 25 25
Difficult to Fold, Unfold or Collapse 15 15
Material Opacification 15 15
Patient Device Interaction Problem 15 15
Activation Failure 13 13
Contamination /Decontamination Problem 11 11
Use of Device Problem 9 9
Scratched Material 9 9
Positioning Problem 8 8
Defective Device 8 8
Failure to Unfold or Unwrap 8 8
Device Markings/Labelling Problem 6 6
Difficult to Insert 5 5
Entrapment of Device 5 5
Crack 5 5
Ejection Problem 5 5
Inaccurate Information 4 4
Missing Value Reason 4 4
Contamination 4 4
Fracture 4 4
Sticking 4 4
Bent 4 4
Difficult To Position 4 4
Malposition of Device 4 4
Activation, Positioning or Separation Problem 3 3
Mechanical Jam 3 3
Optical Distortion 3 3
Particulates 3 3
Product Quality Problem 3 3
Device Slipped 3 3
Optical Decentration 3 3
Mechanical Problem 2 2
Delivered as Unsterile Product 2 2
Difficult or Delayed Positioning 2 2
Material Discolored 2 2
Shelf Life Exceeded 2 2
Failure to Select Signal 2 2
Difficult to Remove 2 2
Output Problem 2 2
Packaging Problem 2 2
Optical Discoloration 2 2
Material Twisted/Bent 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Damaged by Another Device 2 2
Fitting Problem 2 2
Incomplete or Missing Packaging 2 2
Device Handling Problem 2 2
Unexpected Color 2 2
Device Issue 1 1
Tear, Rip or Hole in Device Packaging 1 1
Cut In Material 1 1
Dent in Material 1 1
Split 1 1
Difficult to Advance 1 1
Difficult to Open or Close 1 1
Difficult to Open or Remove Packaging Material 1 1
Folded 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Human-Device Interface Problem 1 1
Pressure Problem 1 1
Material Too Rigid or Stiff 1 1
Device remains implanted 1 1
Unexpected Therapeutic Results 1 1
Failure to Read Input Signal 1 1
Unintended Ejection 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 7167 7167
No Clinical Signs, Symptoms or Conditions 5596 5596
Blurred Vision 1497 1497
Intraocular Pressure Increased 1098 1098
No Known Impact Or Consequence To Patient 927 927
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 596 596
Halo 540 540
Visual Disturbances 514 514
Cataract 495 495
No Consequences Or Impact To Patient 475 475
No Information 258 258
Cataract, Induced 200 200
Pupillary Block 160 160
No Patient Involvement 140 140
Pain 129 129
Corneal Edema 116 116
Headache 114 114
Loss of Vision 112 112
Discomfort 102 102
Inflammation 100 100
Glaucoma 64 64
Visual Impairment 59 59
Endophthalmitis 56 56
Iritis 39 39
Dry Eye(s) 36 36
Uveitis 34 34
Toxic Anterior Segment Syndrome (TASS) 33 33
Retinal Detachment 29 29
Intraocular Pressure, Delayed, Uncontrolled 28 28
Eye Pain 25 25
Corneal Decompensation 24 24
Nausea 13 13
Red Eye(s) 12 12
Foreign Body Sensation in Eye 12 12
Vitrectomy 12 12
Cyst(s) 10 10
Vomiting 10 10
Vitreous Floaters 9 9
Hyphema 9 9
Insufficient Information 9 9
Capsular Bag Tear 8 8
Patient Problem/Medical Problem 7 7
Dizziness 7 7
Edema 6 6
Not Applicable 6 6
Missing Value Reason 5 5
Hypopyon 5 5
Fatigue 5 5
Swelling 5 5
Intraocular Infection 4 4
Vitreous Detachment 4 4
Macular Edema 4 4
Eye Injury 3 3
Corneal Touch 3 3
Conjunctivitis 2 2
Flashers 2 2
Hemorrhage/Bleeding 2 2
Failure of Implant 2 2
Irritation 2 2
Itching Sensation 2 2
Prolapse 2 2
Numbness 2 2
Obstruction/Occlusion 2 2
Excessive Tear Production 2 2
Anxiety 2 2
Retinal Tear 2 2
Increased Sensitivity 2 2
Vertigo 1 1
Optical Nerve Damage 1 1
Pulmonary Regurgitation 1 1
Impaired Healing 1 1
Reaction 1 1
Clouding, Central Corneal 1 1
Overwear Syndrome 1 1
Burning Sensation 1 1
Vitritis 1 1
Vitreous Hemorrhage 1 1
Keratitis 1 1
Low Blood Pressure/ Hypotension 1 1
Corneal Clouding/Hazing 1 1
Hematoma 1 1
Corneal Abrasion 1 1
Corneal Ulcer 1 1
Cyclitis 1 1
Dehydration 1 1
Deposits 1 1
Capsular Contracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Staar Surgical Company II Dec-01-2023
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