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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)
2019 2020 2021 2022 2023 2024
6 1 1 4 0 2

MDR Year MDR Reports MDR Events
2019 1236 1236
2020 1440 1440
2021 2063 2063
2022 1917 1917
2023 2088 2088
2024 1477 1477

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequacy of Device Shape and/or Size 5799 5799
Off-Label Use 2573 2573
Adverse Event Without Identified Device or Use Problem 1702 1702
No Apparent Adverse Event 1625 1625
Misfocusing 893 893
Optical Problem 325 325
Unintended Movement 196 196
Device Dislodged or Dislocated 177 177
Patient-Device Incompatibility 149 149
Improper or Incorrect Procedure or Method 49 49
Appropriate Term/Code Not Available 19 19
Material Opacification 15 15
Insufficient Information 15 15
Patient Device Interaction Problem 15 15
Contamination /Decontamination Problem 9 9
Product Quality Problem 5 5
Ejection Problem 5 5
Inaccurate Information 4 4
Particulates 3 3
Optical Distortion 3 3
Contamination 3 3
Difficult to Fold, Unfold or Collapse 3 3
Optical Discoloration 2 2
Scratched Material 2 2
Packaging Problem 2 2
Unexpected Color 2 2
Material Discolored 2 2
Defective Device 2 2
Mechanical Problem 2 2
Output Problem 2 2
Unexpected Therapeutic Results 1 1
Delivered as Unsterile Product 1 1
Material Too Rigid or Stiff 1 1
Unintended Ejection 1 1
Material Twisted/Bent 1 1
Use of Device Problem 1 1
Device Markings/Labelling Problem 1 1
Crack 1 1
Failure to Unfold or Unwrap 1 1
Break 1 1
Pressure Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6258 6258
No Code Available 1625 1625
Blurred Vision 888 888
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 667 667
Intraocular Pressure Increased 503 503
Visual Disturbances 351 351
Halo 292 292
Cataract 237 237
No Known Impact Or Consequence To Patient 212 212
No Consequences Or Impact To Patient 168 168
Toxic Anterior Segment Syndrome (TASS) 90 90
Inflammation 78 78
No Patient Involvement 59 59
Headache 58 58
Discomfort 54 54
Corneal Edema 53 53
Pain 49 49
Endophthalmitis 47 47
Pupillary Block 41 41
Glaucoma 32 32
Eye Pain 25 25
Retinal Detachment 23 23
Uveitis 21 21
Dry Eye(s) 21 21
Iritis 17 17
Corneal Decompensation 14 14
Foreign Body Sensation in Eye 11 11
Insufficient Information 9 9
Red Eye(s) 9 9
Not Applicable 6 6
Hyphema 6 6
Cyst(s) 5 5
Fatigue 5 5
Visual Impairment 5 5
Vitreous Floaters 5 5
Dizziness 4 4
Cataract, Induced 3 3
Capsular Bag Tear 3 3
Eye Injury 3 3
Nausea 3 3
Loss of Vision 3 3
Itching Sensation 2 2
Corneal Touch 2 2
Flashers 2 2
Swelling/ Edema 2 2
Excessive Tear Production 2 2
Corneal Ulcer 1 1
Optical Nerve Damage 1 1
Keratitis 1 1
Deposits 1 1

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