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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device lens, intraocular, phakic
Product CodeMTA
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
1 1 4 0 4 0

MDR Year MDR Reports MDR Events
2020 1440 1440
2021 2063 2063
2022 1917 1917
2023 2088 2088
2024 2160 2160
2025 70 70

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequacy of Device Shape and/or Size 5047 5047
Off-Label Use 2361 2361
Adverse Event Without Identified Device or Use Problem 2182 2182
No Apparent Adverse Event 1614 1614
Misfocusing 766 766
Optical Problem 256 256
Unintended Movement 177 177
Patient-Device Incompatibility 130 130
Device Dislodged or Dislocated 129 129
Improper or Incorrect Procedure or Method 44 44
Patient Device Interaction Problem 15 15
Appropriate Term/Code Not Available 12 12
Insufficient Information 8 8
Product Quality Problem 5 5
Contamination /Decontamination Problem 4 4
Material Opacification 4 4
Particulates 4 4
Optical Distortion 3 3
Unexpected Color 2 2
Output Problem 2 2
Optical Discoloration 2 2
Scratched Material 2 2
Defective Device 2 2
Ejection Problem 2 2
Mechanical Problem 2 2
Pressure Problem 1 1
Delivered as Unsterile Product 1 1
Inaccurate Information 1 1
Crack 1 1
Difficult to Fold, Unfold or Collapse 1 1
Use of Device Problem 1 1
Material Twisted/Bent 1 1
Contamination 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6744 6744
Blurred Vision 857 857
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 736 736
No Code Available 662 662
Intraocular Pressure Increased 428 428
Visual Disturbances 296 296
Halo 262 262
Cataract 217 217
Toxic Anterior Segment Syndrome (TASS) 136 136
No Known Impact Or Consequence To Patient 91 91
No Consequences Or Impact To Patient 87 87
Inflammation 72 72
Headache 53 53
Discomfort 50 50
Corneal Edema 46 46
Pupillary Block 41 41
Endophthalmitis 33 33
Pain 30 30
Eye Pain 27 27
Glaucoma 23 23
Retinal Detachment 23 23
Dry Eye(s) 20 20
Uveitis 18 18
Iritis 17 17
No Patient Involvement 17 17
Corneal Decompensation 12 12
Insufficient Information 9 9
Foreign Body Sensation in Eye 8 8
Hyphema 6 6
Red Eye(s) 6 6
Fatigue 5 5
Cyst(s) 4 4
Dizziness 4 4
Visual Impairment 4 4
Eye Injury 3 3
Vitreous Floaters 3 3
Loss of Vision 3 3
Capsular Bag Tear 3 3
Excessive Tear Production 2 2
Flashers 2 2
Itching Sensation 2 2
Swelling/ Edema 2 2
Corneal Touch 2 2
Nausea 2 2
Failure of Implant 1 1
Deposits 1 1
Hypopyon 1 1
Optical Nerve Damage 1 1
Increased Sensitivity 1 1
Corneal Abrasion 1 1

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