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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)
2020 2021 2022 2023 2024 2025 2026
1 1 4 0 4 2 2

MDR Year MDR Reports MDR Events
2020 1440 1441
2021 2063 2065
2022 1917 1924
2023 2076 2079
2024 2147 2169
2025 659 659
2026 239 239

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequacy of Device Shape and/or Size 5036 5040
Adverse Event Without Identified Device or Use Problem 2998 3018
Off-Label Use 2360 2369
No Apparent Adverse Event 1615 1622
Misfocusing 764 764
Optical Problem 255 255
Unintended Movement 177 177
Patient-Device Incompatibility 130 133
Device Dislodged or Dislocated 123 124
Improper or Incorrect Procedure or Method 44 44
Patient Device Interaction Problem 19 20
Appropriate Term/Code Not Available 12 12
Insufficient Information 8 9
Product Quality Problem 5 5
Material Opacification 4 4
Particulates 4 4
Contamination /Decontamination Problem 4 4
Optical Distortion 3 3
Mechanical Problem 2 2
Optical Discoloration 2 2
Scratched Material 2 2
Output Problem 2 2
Ejection Problem 2 2
Unexpected Color 2 2
Defective Device 2 2
Unexpected Therapeutic Results 1 2
Use of Device Problem 1 1
Material Twisted/Bent 1 2
Delivered as Unsterile Product 1 1
Contamination 1 1
Crack 1 1
Difficult to Fold, Unfold or Collapse 1 1
Inaccurate Information 1 1
Pressure Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6817 6845
Blurred Vision 1099 1102
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1032 1034
No Code Available 662 662
Intraocular Pressure Increased 520 524
Visual Disturbances 384 384
Halo 324 324
Cataract 283 285
Toxic Anterior Segment Syndrome (TASS) 150 150
No Known Impact Or Consequence To Patient 91 91
No Consequences Or Impact To Patient 87 87
Inflammation 87 87
Discomfort 65 66
Corneal Edema 62 62
Headache 57 58
Pupillary Block 43 43
Endophthalmitis 41 41
Glaucoma 35 35
Pain 31 32
Eye Pain 29 30
Retinal Detachment 25 25
Uveitis 25 25
Dry Eye(s) 21 22
Iritis 21 21
No Patient Involvement 17 17
Corneal Decompensation 13 13
Insufficient Information 9 9
Foreign Body Sensation in Eye 8 9
Red Eye(s) 6 6
Hyphema 6 6
Failure of Implant 5 5
Fatigue 5 6
Dizziness 4 4
Cyst(s) 4 4
Skin Erosion 4 4
Visual Impairment 4 4
Hypopyon 4 4
Capsular Bag Tear 3 3
Eye Injury 3 3
Vitreous Floaters 3 3
Loss of Vision 3 3
Corneal Touch 2 2
Itching Sensation 2 3
Keratitis 2 2
Flashers 2 2
Nausea 2 2
Swelling/ Edema 2 2
Excessive Tear Production 2 3
Corneal Abrasion 1 1
Optical Nerve Damage 1 1

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