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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device phakic toric intraocular lens
Regulation Description Intraocular lens.
Definition Intended to be implanted within the eye to optically correct astigmatism (with or without other refractive errors), without removing the natural crystalline lens.
Product CodeQCB
Regulation Number 886.3600
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 0 0 0 1 0

MDR Year MDR Reports MDR Events
2021 2887 2904
2022 2795 2823
2023 3703 3735
2024 3606 3620
2025 1397 1397
2026 606 606

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequacy of Device Shape and/or Size 6737 6783
Adverse Event Without Identified Device or Use Problem 5104 5114
Off-Label Use 2765 2776
No Apparent Adverse Event 1590 1616
Device Dislodged or Dislocated 1198 1219
Misfocusing 1043 1060
Optical Problem 208 210
Unintended Movement 166 167
Patient-Device Incompatibility 111 115
Improper or Incorrect Procedure or Method 43 43
Patient Device Interaction Problem 13 13
Appropriate Term/Code Not Available 10 10
Insufficient Information 6 7
Particulates 6 6
Material Integrity Problem 4 4
Ejection Problem 4 4
Difficult to Fold, Unfold or Collapse 3 3
Use of Device Problem 3 3
Product Quality Problem 3 3
Contamination 2 2
Compatibility Problem 1 1
Material Opacification 1 1
Scratched Material 1 1
Packaging Problem 1 1
Optical Decentration 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11104 11177
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1745 1762
Blurred Vision 1691 1708
Intraocular Pressure Increased 608 615
Visual Disturbances 323 325
Halo 279 280
Cataract 149 153
Inflammation 100 100
Toxic Anterior Segment Syndrome (TASS) 96 96
Corneal Edema 64 64
Discomfort 48 51
Headache 46 46
Pupillary Block 44 45
Eye Pain 33 33
Uveitis 31 31
Endophthalmitis 30 30
Iritis 26 26
Pain 23 23
Dry Eye(s) 13 13
Glaucoma 12 12
Corneal Decompensation 10 10
Hyphema 9 9
Visual Impairment 8 8
Retinal Detachment 7 8
Red Eye(s) 7 7
Insufficient Information 5 5
Swelling/ Edema 5 5
Hypopyon 5 5
Nausea 4 4
Macular Edema 4 4
UGH (Uveitis Glaucoma Hyphema) Syndrome 4 4
Capsular Bag Tear 3 3
Unspecified Eye / Vision Problem 3 3
Fatigue 3 3
Corneal Clouding/Hazing 3 3
Foreign Body Sensation in Eye 3 3
Dizziness 2 2
Keratitis 1 1
Cyst(s) 1 1
Corneal Stromal Edema 1 1
Conjunctivitis 1 1
Vomiting 1 1
Hernia 1 1
Subluxation 1 1
Vitreous Floaters 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Staar Surgical AG II Mar-02-2026
2 Staar Surgical Company II Dec-01-2023
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