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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
1 1 4 0 4 1

MDR Year MDR Reports MDR Events
2020 1440 1441
2021 2063 2065
2022 1917 1918
2023 2076 2076
2024 2148 2148
2025 528 528

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequacy of Device Shape and/or Size 5036 5036
Adverse Event Without Identified Device or Use Problem 2633 2633
Off-Label Use 2360 2360
No Apparent Adverse Event 1611 1611
Misfocusing 764 764
Optical Problem 255 255
Unintended Movement 177 177
Patient-Device Incompatibility 130 132
Device Dislodged or Dislocated 123 123
Improper or Incorrect Procedure or Method 44 44
Patient Device Interaction Problem 19 19
Appropriate Term/Code Not Available 12 12
Insufficient Information 8 9
Product Quality Problem 5 5
Material Opacification 4 4
Contamination /Decontamination Problem 4 4
Particulates 4 4
Optical Distortion 3 3
Mechanical Problem 2 2
Output Problem 2 2
Defective Device 2 2
Scratched Material 2 2
Ejection Problem 2 2
Unexpected Color 2 2
Optical Discoloration 2 2
Pressure Problem 1 1
Crack 1 1
Difficult to Fold, Unfold or Collapse 1 1
Contamination 1 1
Material Twisted/Bent 1 2
Use of Device Problem 1 1
Delivered as Unsterile Product 1 1
Unexpected Therapeutic Results 1 2
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6783 6783
Blurred Vision 989 990
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 876 876
No Code Available 662 662
Intraocular Pressure Increased 478 479
Visual Disturbances 347 347
Halo 304 304
Cataract 267 269
Toxic Anterior Segment Syndrome (TASS) 144 144
No Known Impact Or Consequence To Patient 91 91
No Consequences Or Impact To Patient 87 87
Inflammation 78 78
Corneal Edema 58 58
Headache 54 55
Discomfort 53 54
Pupillary Block 43 43
Endophthalmitis 38 38
Pain 31 32
Glaucoma 29 29
Eye Pain 27 28
Retinal Detachment 23 23
Uveitis 23 23
Dry Eye(s) 20 21
Iritis 20 20
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
Capsular Bag Tear 3 3
Eye Injury 3 3
Hypopyon 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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