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

MDR Year MDR Reports MDR Events
2021 2063 2065
2022 1917 1924
2023 2076 2079
2024 2146 2168
2025 659 659
2026 569 569

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequacy of Device Shape and/or Size 4070 4074
Adverse Event Without Identified Device or Use Problem 3154 3174
Off-Label Use 1978 1987
No Apparent Adverse Event 1457 1464
Misfocusing 652 652
Optical Problem 202 202
Unintended Movement 143 143
Device Dislodged or Dislocated 110 111
Patient-Device Incompatibility 82 83
Improper or Incorrect Procedure or Method 28 28
Patient Device Interaction Problem 17 18
Appropriate Device Problem Term/Code Not Available 12 12
Insufficient Device Problem Information 5 5
Particulates 4 4
Product Quality Problem 4 4
Optical Distortion 3 3
Defective Device 2 2
Contamination /Decontamination Problem 2 2
Unexpected Color 2 2
Optical Discoloration 2 2
Mechanical Problem 1 1
Material Opacification 1 1
Crack 1 1
Contamination 1 1
Scratched Material 1 1
Ejection Problem 1 1
Delivered as Unsterile Product 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6454 6482
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1112 1114
Blurred Vision 1055 1058
Intraocular Pressure Increased 458 461
Visual Disturbances 329 329
Halo 287 287
Cataract 263 265
Toxic Anterior Segment Syndrome (TASS) 151 151
Inflammation 93 93
Discomfort 61 62
Uveitis 51 51
Corneal Edema 51 51
Headache 44 45
Endophthalmitis 44 44
Pupillary Block 41 41
Iritis 34 34
Glaucoma 32 32
Retinal Detachment 25 25
Eye Pain 24 25
Pain 18 18
Corneal Decompensation 13 13
Dry Eye(s) 9 9
Insufficient Information 8 8
Hyphema 8 8
Red Eye(s) 6 6
Failure of Implant 5 5
Dizziness 4 4
Skin Erosion 4 4
Hypopyon 4 4
Foreign Body Sensation in Eye 4 5
Capsular Bag Tear 3 3
Vitreous Floaters 3 3
Fatigue 3 4
Itching Sensation 2 3
Keratitis 2 2
Eye Injury 2 2
Swelling/ Edema 2 2
Loss of Vision 2 2
Excessive Tear Production 2 3
Corneal Abrasion 1 1
Nausea 1 1
Cyst(s) 1 1
Diplopia/Double Vision 1 1
Macular Edema 1 1
Unspecified Eye / Vision Problem 1 1
Visual Impairment 1 1
Intraocular Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Staar Surgical AG II Jun-18-2026
2 Staar Surgical Company II Dec-01-2023
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